Development Scientist Resume Samples

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M Jast

Mazie

Jast

256 Norris Island

Los Angeles

+1 (555) 552 6739

256 Norris Island

Los Angeles

Phone

p +1 (555) 552 6739

Experience Experience

Philadelphia, PA

Development Scientist

Philadelphia, PA

Fay Group

Philadelphia, PA

Development Scientist

Manage a group of development associates to develop and optimize cell culture processes for the production of therapeutic proteins
Understand risk management concepts and assess product, process, project and schedule risks across unit of work
Plan and perform studies for the development and optimization of raw materials and processes to be used in automated immunoassays
Perform studies for the development and optimization of raw materials and processes to be used in automated immunoassays
Manage a group of Development Associates and have group level objectives
Author and review documentation associated with assay development work
Provide technical/processing assistance to both the client and to the Winchester Manufacturing department

Chicago, IL

Research & Development Scientist

Chicago, IL

Cremin Inc

Chicago, IL

Research & Development Scientist

Follow Training SOP for training and training records
Troubleshooting and creative problem solving independently and in a multidisciplinary team in the areas of chemistry, analytical workflows, and engineering
Help with troubleshooting problems during production and manufacturing
Knowledge of API testing procedures for drilling and completion fluids
Executes experiments, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines
Develop new and improved methods and systems for food processing, production, quality control and packaging
Collaborate with the research & scientific community in vetting next-generation concepts and technologies towards future product innovations

present

Detroit, MI

Senior Development Scientist

Detroit, MI

Feil, Wehner and Hills

present

Detroit, MI

Senior Development Scientist

present

Drive continual improvement in lean product development methodology
Adheres to policies and procedures following research and development scientific standards
Knowledge of development process
Learns to develop and track chemistry project plans
May lead training and guidance of junior scientists; may review and approve junior scientist’s work
Designing and developing protocols and strategies to compliment bead functionality through molecular conjugation and coupling expertise
Recommends and executes changes to processes, procedures or products internally to the department

Education Education

Bachelor’s Degree in Biology

University of California, Irvine

Bachelor’s Degree in Biology

Skills Skills

Knowledgeable about food chemistry, sensory, microbiology, food packaging systems and food engineering
Ability to think in a rational, logical manner
Understanding or experience with an ERP systems is desirable
Excellent organization and interpersonal communication skills
Interact with other groups within Kerry when necessary(applications groups/marketing/production)
Work well with cross-functional teams
Communicate effectively, team player, report results in a conscience manner, stay abreast of current literature
Problem solver, solution seeker, complete given objectives, independently identify experimental work necessary to achieve project objectives, contribute workable creative ideas
Work well in an ambiguous setting, self-motivated, proactive, work with minimal direction
Language/Fluency: English

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15 Development Scientist resume templates

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Principal Development Scientist Resume Examples & Samples

80%
Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines
Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics
Experience with PD/mfg, release testing, formulation development, drug/device characterization
The principal development scientist position will work closely with groups within MRT including Process and Analytical Development as well as external contract organizations, and participate /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product
In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization

Senior DP Development Scientist Resume Examples & Samples

Provide technical leadership in execution of biopharmaceutical product development – 30%
Perform experiments and document results in technical reports – 20%
Author/review development documents and support regulatory submissions and responses – 15%
Lead and/or represent within cross functional project teams (process development, tech transfer, and/or CMC teams) – 15%
Design in-use studies to support administration of drug product in clinical trials - 10%
Minimum, PhD in biology, chemistry, or related science with 5 years of relevant experience in pharmaceutical development and drug product manufacturing or M.S. in biology, chemistry or related science with 8 years of relevant experience in pharmaceutical development and drug product manufacturing
Thorough knowledge of global GMP regulations and guidance
Good knowledge and experience with applying Quality by Design principles and statistical analysis tools for evaluation of drug substance and drug product stability
Excellent oral and written communication skills including the ability to deliver good presentations and well written technical documents

Principal DP Development Scientist Resume Examples & Samples

Provide technical leadership for drug product development and tech transfer activities including life cycle management projects – 50%
Author/review development documents and support regulatory submissions, responses and inspections – 15%
Represent within cross functional project teams including process development, CMC and tech transfer teams - 15%
Design in-use studies to support administration of drug product in the clinic – 10%
Provide Department-wide operations support including establishing more effective systems and processes, technical evaluation of new technologies and contract partners - 10%
Minimum of 10 years of experience in pharmaceutical development and manufacturing
Experience with formulation development and aseptic manufacturing operations for injectable biologics. Late-stage product development experience is strongly desired
Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation
In-depth understanding of protein degradation mechanisms. Strong expertise in protein characterization techniques including chromatography, biophysical, and solution physical property measurements
Good knowledge and experience with applying Quality by Design principles and statistical analysis tools to evaluation of drug product manufacturing process
Must be well-organized and self-motivated, and possess an independent work style
Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy
Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside Shire
Excellent oral and written communication skills including the ability to make good presentations and write good technical documents
Strategic agility and effective program management/leadership skills

Senior Development Scientist Resume Examples & Samples

Exercises judgment within defined procedures and practices to determine appropriate action
Learns to develop and track chemistry project plans
Participates on multifunctional teams and may lead small projects
Knowledge of development process
Designs and conducts experiments independently
Processes and analyzes data using appropriate statistical approaches with limited supervision
Disseminates information to professional colleagues through reports, presentations or data reviews
Reviews and approves junior scientist's work
Reports status of experiments to project team, gives data presentations
Recommends changes to processes, procedures or products internally to the department
Adheres to policies and procedures
May lead process improvement projects, safety or laboratory operations
May participate in hiring
Knowledge of instrument theory of operation
Knowledge of limited/assigned analytes - reaction scheme and performance claims
Keeps current on Standards and trends in Clinical Chemistry
BSc. and 6 years or MSc and 4 years
Experience in IVD R&D essential

Clinical Development Scientist Resume Examples & Samples

Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required
This position may be combined with the GCDL position when the program is limited in its scope and complexity (Director)
100%
Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams
Supports the GDTL/GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs
Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
Act on behalf of GCDL/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Significant experience (7-10 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
Demonstrated ability to collaborate in a matrixed environment
Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or

Senior Development Scientist Resume Examples & Samples

Magnetic bead design, specification, characterization and analysis for use (primarily) in biological assay applications. Creating and designing instrument/equipment test and characterization procedures
Designing and developing protocols and strategies to compliment bead functionality through molecular conjugation and coupling expertise
Supporting product evaluation from external opportunities
Working with cross functional teams to develop Process Validation protocols and project plans and ensure adherence to schedules and project deadlines. Including to drive bead manufacturing efficiency and reliability
Interacting with customers in procedures involving demonstration and technical support
Addressing regulatory issues to enable products that are developed, manufactured or distributed to meet required standards
Through a good working knowledge of CAPA systems, resolving and assisting in the closure of deviations initiated during qualification/validation execution. Initiating and implementing change control activities in accordance with site procedures
Vast productive experience, preferably with PhD or equivalent, relating to development of magnetic bead particles for biological assay applications
Extensive experience in magnetic bead design, characterization, analysis and application is essential
Experience of working within a large-scale industrial environment; CRO or clinical analytical assay setting with working knowledge of Medical Device 13485 Quality Systems Management/medical device experience would be beneficial

Application Development Scientist Resume Examples & Samples

Ph.D. in a relevant scientific discipline--Biology, Biochemistry, Molecular Biology, Genetics, Biotechnology (Ph.D. desirable)
Minimum 6 years' experience in a genomics and/or molecular genetics laboratory with at least 3 years’ experience in industry development or support roles
Be familiar with life sciences and/or healthcare industries including molecular diagnostics, drug development, and translational genomics research
Be familiar with NGS, CE, qPCR and dPCR technology desired
Strong collaborative project management experience and publication track record
Possess extremely strong communication skills, both written and spoken
Be extremely detail oriented and comfortable with accountability on complex work projects and requests
Be comfortable with aggressive timelines and workloads
Basic understanding and competency with sales concepts and processes
Ability to travel when required – up to 50% of time

Development Scientist Resume Examples & Samples

Microbiology (or another biological science related) degree or equivalent qualification
Experience in a microbiological laboratory is preferred but not essential
Proficiency with Microsoft Office software including Excel is required
Competency in basic scientific techniques
Good organisational and communication skills
High energy, with perseverance and the ability to work flexible hours (early start, late finish) in a high pace environment

Application Development Scientist Resume Examples & Samples

Work closely with the Marketing team and with Specialty Fluids Technology to drive growth for Momentive’s Personal and Home Care business
Development of new formulations demonstrating the performance benefits of Momentive’s Personal and Home Care product portfolio based on an understanding of the industry, customer needs and end use applications
Perform laboratory work in support of customer requests, new product launches, quality complaints and assessment of competitive materials
Support of new product introductions including formulation development and data for technical literature
Provide basic customer support related to the use of new and existing products, including travel to customer sites as needed
Support the training of customers, new employees, distributors and agents
Participation in industry trade shows and events
Documentation of laboratory results
Maintain and promote a safe laboratory environment in accordance with applicable quality standards
1 – 3 years of experience in the Personal or Home Care industry in a Product Development and/or Technical Service role
Familiarity with the use and application of common raw materials used in Personal and Home Care
Demonstrated ability to prioritize and handle multiple projects simultaneously and work in a cross-functional team environment with strong customer focus
Demonstrated skill in formulation of Personal and Home Care product forms
Able to effectively communicate results clearly and precisely and document conclusions and recommendations
Self-motivated individual with high level of creativity, technical curiosity and strong team spirit
Ability to occasionally travel regionally

Development Scientist Resume Examples & Samples

Plan and perform studies for the development and optimization of raw materials and processes to be used in automated immunoassays
Independently design, perform, interpret and document experimental studies
Independently analyze simple to complex experimental data
Participate in verification and validation of new and modified product designs
Support the transfer of processes into manufacturing environments and investigation of post-launch performance and/or quality issues
Maintain well-organized documentation in compliance with relevant procedures
Participate in identifying technical issues and recommend resolutions
Remain current on technical literature, internal policies and documentation requirements, and appropriate procedures for assigned projects
Degree in chemistry, biochemistry, or related field (BA/BS + 4 years, MA/MS + 2 years)
Experience with immunoassay development on automated platforms preferred
Experience working in a fast-paced environment that requires multi-tasking and prioritizing required
Experience working in a GMP environment and knowledge of FDA requirements and regulations desirable
Must have effective written and verbal communication skills
Familiarity with statistical techniques desirable
Proficient with MS Office (Word, Excel, PowerPoint)

Development Scientist Resume Examples & Samples

Perform studies for the development and optimization of raw materials and processes to be used in automated immunoassays
Independently analyze simple experimental data
As needed, participate in departmental operations support including material inventory tracking, instrument maintenance, and general laboratory maintenance
Work within a project team, and take direction from a project leader or senior scientist
Responsible for documentation of studies performed and conclusions
Willingness to work in a ISO9000/FDA regulated environment

Senior Development Scientist Resume Examples & Samples

Ph.D. with 0-2 years’ experience, M.S. with 3+ years’ experience of a B.S. degree with 5+ years’ experience in molecular biology, biochemistry, or related field with at least 2 + years’ experience in an assay development, Demonstrated oral and written communication skills with the ability to work in a multidisciplinary team environment
Demonstrated experience with nucleic acid extraction systems and nucleic acid detection systems
Demonstrated experience in assay development, real time PCR, microbiology, virology, cell culture, fluorescent chemistry, nucleotide chemistry, and with automated instrumentation is essential
Demonstrated experience with optimization of enzymes such as polymerases and proteinases

Development Scientist Resume Examples & Samples

Participating in development and commercialization of immunoassays for the Access system
Be able to work under the direction of others; project and technical team leads
Able to independently analyze simple experimental data as well as provide and present conclusions
Able to work with collaborative and often cross functional teams
Responsible for documentation of studies performed; includes materials, methods, and conclusions
Willingness to work in an ISO9000/FDA regulated environment

Senior Development Scientist Resume Examples & Samples

Strong technical background in high complexity, multi-color flow cytometry assays
Experience in development of flow cytometry clinical diagnostics to support FDA clearance, including initial development and feasibility activities, characterization, verification and validations, transferring to manufacturing
Knowledge of ISO 13485 and 21CFR820 (FDA QSR)
Understanding of IVD and design control requirements
Meticulous attention to detail, proficient reasoning and problem-solving skills in experimental design, data analysis and interpretation
Experience with creation of traceability documentation (design outputs to design inputs) for design controls
Demonstrate expertise in the design, execution, and data analysis (including various statistical analysis tools, like JMP or Minitab)
Ability to work collaboratively fostering professional, constructive relationships as part of a team while also working independently to produce data and meet challenging timelines and goals
Excellent organization skills and time management skills to be able to efficiently evaluate, prioritize and handle multiple tasks and priorities
Demonstrate ability to communicate effectively both orally and in writing with colleagues and various functions throughout the organization

Research & Development Scientist Resume Examples & Samples

Planning, organization and execution of research that includes conception, implementation, and experimental evaluation. Primary focus will be on new and improved instrumentation and chemistries for electrophoretic separations and detection
Presentation and documentation of research accomplishments in the form of invention disclosures, internal reviews and reports, peer-reviewed publications, and presentations at international scientific conferences
Collaborate with the research & scientific community in vetting next-generation concepts and technologies towards future product innovations
Troubleshooting and creative problem solving independently and in a multidisciplinary team in the areas of chemistry, analytical workflows, and engineering
Collaborate with product marketing and engineering resources on the decomposition of top-level requirements to develop specifications for new product development
Provide scientific and technical support of both internal and external customers and collaborators
PhD (preferred) or Master's degree plus significant experience in Chemistry, Engineering, or Applied Science, or its equivalent
Experience with capillary electrophoresis, microfluidics, and optical detection (including UV absorbance, laser induced fluorescence, and fluorescent labeling chemistries)
Experience with mass spectrometry and coupling microfluidic separations with MS is advantageous
Demonstrated experience (3+ years) in design and development of analytical instrumentation, preferably in a commercial setting using an established design and development process
Strong instrumentation design (prototyping) and troubleshooting skills are required
Demonstrated track record of achievements in original research

Development Scientist Resume Examples & Samples

Experience in various nucleic acid extraction and purification techniques
Expertise in various common molecular biology techniques, qPCR
Expertise with common bioinformatics tools
Experience working with specimens of human origin
Familiarity with biohazard requirements
Background in microbiology is advantageous
Background or experience with design of experiment (DOE) and biostatistics is advantageous
Experience in operating robotics, an advantage
Experience working in a regulated environment
Experience in motivating people and process ownership
Full knowledge of industry standards and practices
Speaking and writing skills in English, is must

Assay Development Scientist Resume Examples & Samples

A minimum of bachelor's degree (B.S. or B.A.) in a scientific discipline, or medical technology with 4+ years relevant experience, or a master’s degree with 2 years relevant experience, or a PhD degree
Technical expert on nucleic acid extraction or amplification
Experience with nucleic acid extraction systems and nucleic acid detection systems
Experience with optimization of molecular processes or methods
Experience in creating experimental designs, protocols, engineering designs, plans and procedures with review
Experience in independently executing defined Protocols and Procedures and contributes to technical reports within unit of work
Use of statistical tools such as JMP software or Minitab is desirable
Ability to problem solve is preferred

Senior Assay Development Scientist Resume Examples & Samples

A minimum of a Master’s degree with 5+ years relevant experience, or a PhD degree with 2+ years relevant industry experience
Strong oral and written communication skills with the ability to work in a multidisciplinary team environment
Creates and reviews experimental designs, protocols, engineering designs, plans, procedures and reports to achieve business objectives
Has worked on project teams that have commercialized IVD assays
Awareness and routine use of scientific literature and industry standards and regulations such as ISO, CLIA, etc. and how they relate to internal policies and procedures
Competency in statistical analysis programs such as SAS, JMP, and/or MiniTab
Experience in Bioinformatics is desirable

Senior Leader Development Scientist Resume Examples & Samples

Provide technical oversight and guidance to experimental design, execution, analysis and documentation to support new product development
Create innovative reagent kits and research products to meet customer needs
Lead RD scientists and cross-functional partners to define and translate new product requirements into product designs and performance specifications
Cultivate innovative technical solutions to new product design
Collaborate with internal and external partners to achieve project objectives and deliver timely innovative solutions to meet business needs
Provide subject matter expertise to support the development of the strategic plan and funnel of new product opportunities
Work with Program Manager to support daily management of project timelines to enable accurate projection of milestone completion dates and effective prioritization of tasks
Industry experience required (5+ yr)
PhD required (10+yr post-degree)
Deep technical expertise in NGS library construction and nucleic acid isolation methods
Experience with design and development of consumable or reagent assays for research and/or clinical diagnostics highly desired
In depth understanding of chemical or mechanistic interactions between nucleic acids and surfaces, reagents, or other molecules highly desired
Experience with NGS sample preparation and library construction highly desired
Knowledge and mastery of phase-gated development processes in regulated environments
Ability to understand complex scientific and engineering concepts
Proactive, results-oriented, self-motivated team player with strong organizational skills and excellent written and verbal communication skills

Senior Development Scientist Resume Examples & Samples

Ph.D. with 0-2 years’ experience, M.S. with 3+ years’ experience or a B.S. degree with 5+ years’ experience in molecular biology, biochemistry, or related field with at least 2 + years’ experience in an assay development, process engineering or technical transfer role with a diagnostics or pharmaceutical company. Instrumentation experience preferred
Demonstrated expertise in molecular biology techniques and tools for the handling of nucleic acids in extraction, purification, detection and quantification
Demonstrated experience in the characterization of reagents and standards for DNA/RNA and immuno assays
Demonstrated experience in the development of reagent preparation methods and test protocols for transfer to manufacturing
Working knowledge of ISO13485 and GMP quality systems with demonstrated experience working in a BSL-2 laboratory environment under ISO 13485 or GMP preferred
Experience with application of Lean, 6Ʃ, and 5S principles to problem solving and continuous improvement
Strong ability to write, present and communicate verbally in a clear manner and be able to work in a multidisciplinary team environment is paramount
Trained in statistical methods necessary for successful technical transfer including DOE, process and test method validation
Demonstrated experience in the following areas: assay development, process engineering, fill finish operations, writing documents
Ability to perform work independently and demonstrated ability to problem solve

Cell Culture Development Scientist Resume Examples & Samples

Design experiments with sound scientific rational and logic
Support troubleshooting of technical issues and process improvement for higher production efficiency
Ph.D. in biological science, biotech/bioengineering or other related areas
Minimum 3 years of experience in pharmaceutical or biotechnology field, or a master's degree and 6 years of experience in a related field
Extensive knowledge of multiple mammalian cell lines (especially hybridoma) and their growth requirements
Proficient knowledge and hands-on experience with various platforms used for hybridoma production, the expertise with large scale cell culture using bioreactors, stirred tank bioreactors, hollow fiber reactors along with batch, fed batch and continuous production methods
Strong hands-on experience of large scale antibody production process from hybridoma cell culture
Strong technical reporting and good presentation skills
Must be able to effectively communicate throughout the organization from Sr. Management to floor personnel and from Research to Manufacturing team members
Analytical experience with protein/antibody quantitation methods/assays, LAL testing, qPCR
Prior experience with ERP/MES systems is preferred
Prior ISO13485 or QSR or GMP experience is preferred
Experience with cost modeling is preferredSkills

Development Scientist Resume Examples & Samples

Plan and execute development projects
Work with customers to develop and optimize robust formulations and processes at the pilot scale that will be forward processed to scale-up trials
Develop products and service offerings to support internal initiatives
Provide technical/processing assistance to both the client and to the Winchester Manufacturing department
Provide professional customer service (including monitoring of customers in the plant to ensure personal safety and confidentiality)
Assist in preparation of timelines, batch records, protocols and other project related functions
Document results of development trials
Provide process related training to operators, supervisors and quality personnel that are involved in the project
Communicate and coordinate clearly / extensively with customer and other departments to achieve project goals
Doctorate’s degree and at least one year related experience in the pharmaceutical or biotech industries
Master’s degree and at least six years related experience in the pharmaceutical or biotech industries
Bachelor’s degree and at least ten years related experience in the pharmaceutical or biotech industries
Degrees in Pharmaceutical Sciences, Formulation Sciences, Chemical Engineering or Pharmacy are preferred
Experience with pre-formulation validation is preferred
Experience working with solid-dosage forms is preferred
Experience developing oral solid dosage forms with an expertise in particle coating and fluid bed-technologies is preferred
Advanced knowledge of particle and tablet coating, fluid bed processing, high shear granulation is preferred
Ability to translate customer needs and requirements to the operations / manufacturing process in order to support business needs and meet customer deadlines is required
Experience planning, managing and executing complex projects across multiple functions and at times across multiple facilities is required
Demonstrated ability to learn and apply unfamiliar technical principles and techniques with minimal training is required
Experience supporting and driving Environmental Health and Safety initiatives is preferred
Ability to work in a fast paced customer focused environment is required
Excellent communication and negotiation skills are required
Completion of administrative duties as indicated by position
Data entry and use of computer user interface tools including mouse, keyboard and any other applicable instruments
Lifting and operating in an office environment

Senior Quality Control Development Scientist Resume Examples & Samples

Supervise QC Analysts in the Reagent Manufacturing and Quality group with direct management responsibilities including hiring, goal setting, professional development, mentoring, & training
Ensure reagent and consumable QC testing is performed according to the laboratory’s standard operating procedures and within anticipated turnaround time
Draft, review, and update reagent quality control procedures and document any planned or unplanned deviations
Responsible for the review and approval of test data for raw materials and reagents manufactured in-house
Participate in cross-functional team efforts to develop, validate, and implement quality control test methods for new reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies
Collaborate with Biostatistics and Quality to trend QC testing data on key reagents and consumables over time to provide insight into supplier process capabilities and detect indications of special cause variation in incoming lots
Assist in investigation and resolution of reagent / consumable-related issues with our laboratory processes (e.g. investigating special cause variation, changes in failure or repeat rates, other unusual behavior of reagents, consumables, or data), including assessment of impact, root cause identification, and appropriate corrective and preventive action
Bachelor of Science in Molecular Biology or related field with 8+ years of industrial experience
Working knowledge of local, state, and federal laboratory regulations
Knowledge of analytical methods for enzyme activity assays, oligonucleotide purity and composition using HPLC and spectroscopic techniques, and qPCR-based functional testing. Experience with quality testing of next generation sequencing reagents a plus
Strong communicator with ability to maintain open communication and collaboration with internal employees, managers and customers as needed
Solid management and leadership skills and ability to integrate and apply feedback in a professional manner to guide individual staff development
Ability to prioritize and drive to results with a high emphasis on quality
Strong desire to work in a dynamic interdisciplinary team environment

Consumables Development Scientist Resume Examples & Samples

Identify, test and develop new materials, surface modifications, conjugation/modification chemistries, and chemical and biochemical detection technologies for biological/genetic assays
Design, develop, characterize and optimize surface chemistries on a variety of substrates
Develop analytical test methods to evaluate the potential scalability and robustness of new chemistries
Development of Metrology and QC methodology for thin films and surface functionality
Work with Assay development and consumable engineers to integrate new biology and detection chemistries into next-gen array platforms
Independently plan and conduct experiments; analyze, interpret and understand large data sets from both biochemical and physical studies to make timely recommendations based on sound evidence
Troubleshoot and optimize processes in collaboration with external suppliers, other internal research and development groups and internal manufacturing
Conduct focused research independently, with minimal supervision, and pro-actively generate ideas
Train junior R&D and operations personnel in new techniques and processes
Track record of innovation in the field of advanced materials, surface chemistry, biomaterials or consumable development for biological/genomics assays
Hands on experience developing surface chemistry for consumer products. Experience with bioconjugation, bio-surface interactions or development of chemistries for consumables a plus
Deep technical understanding of surface characterization including but not limited to: AFM, STM, Optical/fluorescence microscopy, spectroscopy, ellipsometry, XRF, XPS
Experience with fluorescence based assays

Assay Development Scientist Array Development Resume Examples & Samples

Design high-throughput chemistries for array products
Develop molecular biology tool set for improving assay performance
Provide input, direction and critical parameters to the consumable development group based on physical and biochemical assay requirements
Generate relevant model systems and apply pertinent controls to expedite cycles of learning
Data pipeline and analysis for large data sets supporting both Development, V&V and manufacturing
Statistical analysis of large data sets to determine/define assay performance, including LOD, Specificity, robustness…
Hands on experience with DNA or antibody-based assays, microarrays and sequencing
Design of sequencing/genomics methodologies
Track record of innovation in the field of high-throughput chemistries for genomics assays
Strong understanding of molecular biology, biochemistry, and biophysics
Coding (R, C+, Python); Image analysis is a plus
Advanced statistical analysis, formal Design of Experiment, DOE, statistical software (JMP, Minitab)
Understanding of performance metrics related to genomics assays

Development Scientist Resume Examples & Samples

Development of a simulation tool to predict heat transfer performance and energy consumption of commercial HVAC system & components, including air handler, air cooled, water Glycol, Chilled water system, air refrigerant evaporators, air-water heat exchanger, air to air heat exchanger, micro-channel heat exchangers, air-refrigerant condensers, compressors, etc
Heat transfer analysis of commercial HVAC system & components
Test data reduction and analysis
Technical support of existing products within the organization using in-house software and/or commercial tools
Search and review the latest technical publications on refrigeration, heat transfer, thermal science and fluid mechanics
Select and apply the best suitable technology of thermal science, refrigerant, heat transfer and fluid mechanics on modeling of HVAC system and component performance
Select and apply the fast possible technology of thermal modeling if required
Apply the best suitable numerical method to create efficient algorithm to deliver the fast, convergent and robust modeling of HVAC system and component performance
Documentation and presentation to senior management on the progress of projects
Masters degree in mechanical engineering preferred
Strong background on fluid mechanics, heat transfer, refrigeration and thermodynamics
Experience with refrigerant to air or other fluid heat exchangers (fin and tube and micro-channel), HVAC system modeling, VB.Net or other high level programming languages
Experience and knowledge of heat exchangers (fin and tube, micro-channel, shell and tube, co-axial and brazed plate)
Experience and knowledge of validating HVAC computer models against test data
Experience with VB.net, C#, C++ or other object oriental programming languages
Knowledge of numerical methods
Proficiency in Microsoft Suite Applications (Word, Excel, PowerPoint, Project, et al) as well as Internet software and E-mail
Good understanding of Liebert cooling product
Good understanding of DOE and AHRI requirement
Strong team effort mentality
Excellent verbal and written communication skills in English and the ability to express thoughts and ideas clearly
Bachelor in Mechanical Engineering or related technical field and
Minimum 7 years experience in system modeling and heat transfer analysis of commercial HVAC product and components
OR Masters Degree in Engineering with 4 years directly related experience

Systems Development Scientist Resume Examples & Samples

COTS Software Integration experience
Microsoft Windows XP Internals experience
Programming Language experience
TCP/IP
LAN and Networking experience

Development Scientist Resume Examples & Samples

Experienced individual contributor with considerable understanding and application of IVD assay development, microbiology, virology, cell culture, nucleic acid extraction systems, amplification technologies, and nucleic acid detection systems
Experienced in characterization of enzymes for processing of molecular methods
Developing as a subject matter expert in molecular diagnostics assays, microbiology, and/or enzymology
Applies critical thinking to trouble shooting efforts that support project objectives
Accountable for project decisions within unit of work
Ability to prioritize work to accomplish project goals

Development Scientist Resume Examples & Samples

Develop and optimize robust, scalable purification processes for GMP manufacturing of biologics for clinical and commercial supply
Lead process scale up evaluation and process tech transfer
Lead small-scale validation and process characterization studies
Lead and present technical and organizational updates both internal and external as needed
Author technical protocols, reports and peer-reviewed external journal articles
Serve as subject matter expert for purification processes across Alexion internal and external manufacturing network for clinical and commercial processes
Manage a group of Development Associates and have group level objectives
Must have extensive technical knowledge of purification operations for biologics including chromatography and filtration
Must have demonstrated technical proficiency, scientific creativity, ability to collaborate with others
Must have good oral and written communication skills are essential with experience in writing and reviewing process-related documents
Experience using AKTA systems and unicorn software for purification development is preferred
The ability to troubleshoot purification processes and instruments in area of expertise, and to offer solutions is preferred
Knowledge of scientific principles and concepts in the field of chromatography and filtration is preferred
Preferred if possess working knowledge of regulatory guidelines related to purification development including viral clearance and process validation

Development Scientist Resume Examples & Samples

Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in Biology, Biochemistry, Molecular Biology, Virology, Cell Biology, Microbiology, Pharmacy, or other related scientific discipline or eight (8) years relevant experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of two (2) years of progressively responsible job related experience
QPCR development and optimization
Cell-based bioassay design, development and optimization
Viral characterization, transfection, and titering assays
Experience with technical trouble-shooting and problem solving in a product development or analytical laboratory setting
Ability to develop, optimize, validate, and document analytical test methods for novel biopharmaceuticals, including: qPCR and sequence-based detection and quantitation, binding assays (e.g. ELISA, BIAcore, etc.)
Ability to conduct a variety of cell-based assays including transgene expression, proliferation, apoptosis, viral titer, and metabolic/biochemical reporters for activity and potency determination in a CGMP laboratory environment

Senior Technology Development Scientist Resume Examples & Samples

Manage in full autonomy complex Technology and Science Development projects focused on innovation in Nutrition, Health & Wellness
Strong collaboration with external partners in science, with R&D entities in Nestlé and General Mills, expert networks as well as regulatory and nutrition function
Proactively communicate to R&D stakeholders and to the business the progress of the technology development projects
Involved in cross-functional teams to take new technologies and science solutions to commercial implementation
Capture knowledge developed throughout projects and train R&D for the deployment of the technology
Propose new ideas and contribute to the development of our Science & Technology innovation pipeline
Master in Food Science or Technology or equivalent
At least 3 years’ experience in Cereal technologies and in Health and Nutrition
At least 5 years’ experience in strong & successful R&D Project Management
Working experience in food industry and international fast-paced environment
Experience in product innovation & renovation is an asset

Cell Culture Development Scientist Resume Examples & Samples

Design experiments with sound scientific rational and logic. Design of Experiments (DOE) experience a plus
Objectively evaluate alternative production methods for medium to large scale cell culture production
Ph.D. in biological science, biotech/bioengineering or other related areas plus a minimum 3 years of hands-on experience in pharmaceutical or biotechnology field, or master's degree plus 6 years of hands-on experience in related field
Proficient knowledge and hands-on experience of various platforms used for hybridoma production, the expertise with large scale cell culture using bioreactors such as WAVE, stirred tank bioreactors, hollow fiber reactors along with batch, fed batch and continuous production methods
Strong technical reporting and good presentation skills are required
Must be able to effectively communicate throughout the organization from Sr. Management to floor personnel, from Research to Manufacturing team members

Assay Development Scientist Resume Examples & Samples

Design and conduct experiments and troubleshooting activities to support new product development and resolve technical issues
Compile data and prepare technical reports for presentation to the management team or outside research community
Develop, optimize, and determine feasibility of new assays
Work independently and within project teams to design, perform, and analyze experimental studies
Work with software teams to develop and deliver user interface systems and bioinformatics tools
Develop and track project plans to meet milestones
Maintain detailed records and documentation

Clinical Development Scientist, Oncology Resume Examples & Samples

May interact with internal and external stakeholders (study sites, committees, etc) in support of clinical study objectives
Experience in clinical trial design and authoring clinical development documents / summarizing clinical study results
Must collaborate with internal and external individuals involved in program development and must effectively manage resolution of scientific issues across protocols
Must have understanding of clinical research process from program planning to submission
Demonstrated ability to mentor individuals responsible for the execution of scientific aspects of clinical trials, including medical data review

Assay Development Scientist Resume Examples & Samples

Provide technical support to develop new assays and to enhance current methodologies
Assist Director of QC to recognize the most suitable protocol for each assay
Collaborate with colleagues for optimization of the laboratory processes for increased efficiency
Plan, design and execute various scientific investigations to support the development of assays
Ensure that all development studies adhere to FDA standards
Generate reports pertaining to assay development
Support manufacturing team to ensure timely project delivery
Manage lab inventory for new and existing projects
Resolve Technical and workflow issues in a timely fashion
Consistently achieves individual goals
Consistently completes work effectively and efficiently
Key contributor to product quality
Minimum BS in a life sciences discipline with 8+ years of experience in GMP/GLP environment OR MS in life sciences with 4+ years of experience in GMP/GLP environment required
Demonstrated experience and proficiency with Mammalian cell culture required

Development Scientist Resume Examples & Samples

Design and execute pre-formulation screening and formulation development studies for preclinical and clinical stage biopharmaceuticals (20%)
Design and execute clinical material compatibility and dosing solution stability studies for clinical product candidates. (20%)
Author technical reports for the development, implementation of test methods, support submissions for IND and draft reports for regulatory filing (20%)
Manage stability studies for clinical development candidates. (15%)
Analyze and interpret analytical data. (5%)
Support technical transfer and validation activities (5%)
Participate in cross-functional process development teams representing Pharmaceutical Development (5%)
Seek out and evaluate new instruments, methods, techniques and technology platforms to enhance formulation and analytical operations (5%)
Present results in internal and external meetings (5%)
PhD with 1-2 years, or MSc with at least 4 years or BSc with suitable experience in pharmaceutical sciences, biochemistry, biological sciences, chemistry or other relevant discipline or in a pharmaceutical development capacity in the pharmaceutical or biotech industry
Position requires scientific and practical knowledge of general test methods for analyzing protein therapeutics including monoclonal antibodies and glycoproteins
Experience with assay development, optimization, qualification and validation for protein therapeutics is a significant plus
Position requires an overall understanding of protein degradation pathways and expertise in the analytics to identify and track such degradants as well as to formulate around such issues
Scientific understanding of factors impacting protein stability
Ability to take initiative in problem solving
Knowledge of cGMP and quality guidelines
The individual must be able to work in a collaborative setting
Ability to adhere to timelines is essential
Excellent interpersonal skills are required, as is the strong ability to communicate effectively

Formulation Development Scientist Resume Examples & Samples

Development of drug products for clinical trials and commercialization with a focus on oral, parenteral, or intranasal dosage forms
Conduct research in the area of formulation sciences in support of product development both for new chemical entities and life-cycle management of marketed products using innovative and modern techniques
Interact effectively with a multi-disciplinary team of scientists to design robust formulations, process optimization, and technology transfer to Contract Research/Manufacturing Organizations
Contribute to CMC regulatory documentations, patent filings, and IP strategy development
Demonstrate scientific excellence through strong laboratory experimental skills, data analysis, technical report writing, presentations, and publications
PhD or equivalent in Pharmaceutical Sciences or Pharmaceutics with 0-5 years of experience in formulation development
An in-depth understanding of materials science, formulation principles, CMC requirements as well as ability to work independently or in a team
Excellent oral and written communication skills, strong organization and interpersonal skills

Development Scientist Resume Examples & Samples

BSc/BEng degree (or equivalent/relevant experience)
Significant experience in a technical/science based discipline
Willing to travel (domestic travel) – 10%
Strong level of scientific knowledge
Strong practical ability and ability to interpret results effectively

Development Scientist Resume Examples & Samples

Normally receives no instruction on routine work and general instructions on new assignments
Follows standard practices and procedures to prepare experimental protocols and conduct experiments
Analyses experimental data, reports outcome of experiments to supervisor, prepares experimental reports and identifies performance issues
Participates in process improvement projects
Explains technical concepts and experimental outcomes to non-technical team members and gives data presentations to a technical audience
Trains new Development Scientists on instrument set up/maintenance and department processes

Development Scientist Resume Examples & Samples

Normally receives instruction on routine work and on new assignments
Follows standard practices and procedures to prepare basic experimental protocols and conduct experiments
Analyses experimental data, reports outcome of experiments to supervisor and prepares experimental reports

Research & Development Scientist Resume Examples & Samples

Planning, organization and execution of research that includes conception, implementation, and experimental evaluation. Primary focus will be on new and improved instrumentation and workflows for low flow separations and detection, including coupling with mass spectrometry
Presentation and documentation of research accomplishments in the form of invention disclosures, internal reviews and reports, and scientific publications and presentations
Support the product development life cycle, including system design, characterization, verification and validation, and commercial product support
Experience with high performance liquid chromatography, separations science, and detection
Experience with mass spectrometry and coupling nano and microflow separations with MS is advantageous

Recombinant Antibody Development Scientist Resume Examples & Samples

Cloning antibody genes from hybridoma clones and/or primary B cells
Testing recombinant antibody expression in pilot experiments using different expression systems as instructed
Analyzing results and preparing recommendations for improvement or trouble shooting
Helping with buffer preparation to support large scale protein expression and purification
Other job duties may involve tasks such as inventory maintenance and record keeping
For Scientist position: PhD in Molecular Biology, Cell Biology, Immunology, or related Biological Science area; for Research Associate position: Bachelor's degree in Biochemistry, Molecular Biology or related Biological Science area
Experience with molecular cloning, PCR, DNA/RNA extraction, tissue culture, protein expression and purification in different expression system, or willing to learn the skills
Familiar with Microsoft Word, EXCEL and PowerPoint and DNA and protein analysis software, such as Vector NTI
Must be a motivated team player and fast learner with commitment to quality, attention to detail, and strong problem solving skills
Excellent written and verbal communication skills are required
Experience with tissue culture is preferred
Experience with a variety of purification strategies, including both affinity and conventional chromatography methods, is highly desirable
Experience with FPLC is a plus
Experience with antibody engineering, such as phage display and yeast display is a plus

Senior Clinical Development Scientist Resume Examples & Samples

Provides strategic and scientific clinical research leadership to support product registration(s) and life-cycle through development of innovative evidence generation strategies
Deliver excellence in clinical trial design, leading development of clinical documentation
Leads project management in terms of timelines, quality/compliance and budget
Collaborate across different functional areas within Clinical Affairs (Clin Ops, Biostatistics, Data Mgt) to ensure alignment with business objectives
Build collaborative relationships with key internal and external partners and stakeholders, including regulatory agencies, CROs, Scientific Advisory Boards, etc
Act as a Subject Matter Expert in clinical trials involving moderately complex design issues
Create strategies to achieve rapid, cost effective and well-executed clinical studies across multiple regions
Ensure strong scientific lead in the reporting and interpretation of results, including support for registration and dissemination of evidence in peer-reviewed journals
6+ years related scientific / technical experience, including 3+ years role within Clinical Research in In-vitro Diagnostics or Medical Device
Experience in delivering clinical programs within clinical research setting, on time, within budget and in compliance to SOPs and regulations
Ability to deliver critical milestones
Leadership requirement – ability to influence, shape and lead without direct reporting authority
Experience in medical and scientific writing
Excellent oral and written communication skills (English) are necessary
Experience with working in an international environment is recommended
Medical background and international network in IVD or Medical Device
Experience in emergency medicine and point-of-care testing is a plus

Senior Research & Development Scientist Resume Examples & Samples

Apply creativity and innovation in designing products that meet customer needs. This will involve the selection of antibodies, antigens and other critical materials
Become the expert across our parent company (Alere) for the technology used and how it is implemented in lateral flow DOA immunoassay products
Use analytical techniques to characterize what influences product performance and conduct optimization studies to get to the best design
Define, author, and execute verification and validation studies and summarize relative data in reports
Resolve issues identified during studies or other steps towards final development
Author documents to support the Quality System (Planned Deviations, Unplanned Deviations, CAPAs, technical justifications
The senior scientist must be an team-oriented, open-minded individual who is capable of managing their own aggressive timelines with minimal supervision

Principal DP Development Scientist Resume Examples & Samples

Minimum, M.S. degree in biology, chemistry, or related science
Minimum, 10 years of relevant experience in pharmaceutical development and manufacturing
Expertise in protein pre-formulation and formulation development, lyophilization, and strong analytical and biophysical characterization skills

Color Development Scientist Resume Examples & Samples

Works with compound formulations, focusing on blending, compounding and secondary steps in conversion including injection molding and film extrusion
Will be required to learn color matching and the process to scale-up, as well as optimize dispersion
Will be required to learn and support color matching through the compounding and injection molding of materials. Candidate will complete extrusion, molding and some color testing
Will work closely with our color matching team to develop and optimize color matches based on end application and customer requirements. Focus will be on the material requirements for the applications, as well as the critical color and additive packages
Seeks out new techniques and methods to continuously improve color matching, blending, compounding and conversion effectiveness and quality
Must be able to take lead on collecting data during processing and to clearly communicate back to Sr. Technology Manager. Information will be critical to scale-up and plant support for commercial orders
Must have strong analytical and computer skills. The scientist will be focused on problem solving and creating databases to support our projects
Must be able to write comprehensive reports on findings and report out to both the Sr. Technology Manager, as well as the business development team on findings
Will communicate directly with customers, internal sales and marketing
Must be able to communicate well and collaborate with other departments as a team member on projects
Working with Sr. Technology Manager, develop new pigment palettes for high temperature polymers and medical polymer applications. Requires accuracy and knowledge of color database set-up
Customer focused individual, who must be able to speak directly with internal and external customers regarding technical issues
Minimal travel may be required to support plant and customer needs
Off shift work may be required to commercialize formulations and support the initial production run
Bachelor’s degree in chemistry, chemical engineering. polymer engineering or other related field
Ideal candidate would have some exposure to color matching. The candidate may have had formal color training (eg, Terra Community College)
Understanding of various plastic resins and their chemistries
A basic knowledge of pigments and additives is a plus
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
Must be able to read and understand MSDS sheets and processing guides for a variety of raw materials
Ability to complete multiple projects with deadlines
Must be willing and able to complete to work on extruders, molding machines and batching equipment in order to under technology and to further enhance learning experiences
Creative and innovative problem solving skills
Knowledge of statistic process control, design of experiments or other related process improvement methods is a plus
Good color vision is mandatory. Will be required to take a color acuity test
Must be proactive and self-motivated
Strong proven leadership and management skills
Must be able to work shifts as the work load changes or when plant support is required on scale-up
Must be able to work overtime as required
Prefer 5+ years of related experience, or an equivalent combination of education and experience
Experience in engineering plastics coloring and compounding is preferred. Additional background or experience with color matching is ideal
Requires standing and sitting for prolonged periods of time
The employee is occasionally required to stoop, kneel, crouch or crawl
Must be able to lift 50-pound bags and move 250-pound drums (with a hand truck)
May work is in a manufacturing environment where the noise level is moderate to loud
While performing duties of this job, the employee is exposed to mechanical parts, toxic or caustic chemicals, fumes or airborne particles

Translational Development Scientist Resume Examples & Samples

Mastery of basic and advanced lab skills
Able to independently design experiments with scientific rationale
Reviewing literature for technical and scientific support
Proficient with laboratory procedures and instrumentation, including cell culture, basic cellular assays (e.g. proliferation/apoptosis), immunofluorescence, western blot, RT-PCR
Effective team building and teamwork skills and ability to interact with research scientists, project teams, and commercial vendors
Recognizes risk and develops contingency plans
Troubleshoot
Search literature for targeted information
Understand and execute on role tasks
Actively participate in the development of cell-based assays for mechanistic studies, including biomarker work
Perform molecular, biochemical, and cell biological techniques such as cell culture, immunofluorescence, immunoprecipitation, western blot, RNA preparation and mammalian cell transfections
Perform a wide range of assigned research experiments with efficiency, accuracy and attention to detail
Meticulous record keeping
Willingly share information and resources
Cultivate positive and productive working relationships with colleagues
Respectful of laboratory safety policies and practices
Provides input into experimental designs

Bioprocess Development Scientist Resume Examples & Samples

Lead, design, and conduct cell culture experiments using high throughput cell culture methods, benchtop bioreactors and/or pilot scale Single-Use Bioreactors
Perform data analysis, prepare technical reports, SOPs, and internal presentations
Develop, maintain and demonstrate knowledge of concepts, principles, and techniques in upstream continuous biomanufacturing
Demonstrate insight on important new technologies and published literature, attend external scientific forums, and publish in relevant bioprocess journals
Foster effective cross-functional communications across bioprocess disciplines and departments
Ph.D. in Chemical Engineering, Biochemical Engineering, Cell Biology, Biochemistry or related fields and 0-2 years of relevant industry experience
In-depth knowledge of perfusion-based cell culture technologies and operations
Substantial knowledge of mammalian cell culture process technologies and their applications
Hands on experience with bioreactor systems at various scales
Understanding of high throughput cell culture systems and related automated liquid handling technologies
Experience with Design of Experiments (DOE) methodology for process development and characterization and related process data analysis
Exposure to formal technology transfer procedures and strategies
Demonstrated ability to function well within a fast-paced, dynamic and collaborative team-oriented environment
The candidate should be self-motivated, strongly driven to succeed, inquisitive and innovative, and have excellent organizational, interpersonal, communication and problem-solving skills

Development Scientist Resume Examples & Samples

Have a degree or equivalent in microbiology or a microbiology related topic
Competent in basic scientific techniques
Experience of techniques used in microbiology laboratories including microbiological testing of food or clinical samples would be desirable but not essential
Proficiency with office software packages including Excel is required. Knowledge of Microsoft Project is preferable

Intern / Research & Development Scientist Resume Examples & Samples

Currently pursuing a Master’s or Ph.D. degree in Electrical, Aerospace/Aeronautical or Computer Science
Must be able to participate in an internship, prior to completing current degree program
Basic understanding of inertial navigation, GPS, and integrated navigation a plus
Engineering experience related to the Navigation and/or Autonomous Guidance field a plus
Experience with unmanned air vehicle (UAV) sensor integration and testing
Exposure to non-inertial navigation techniques, image processing/computer vision, etc
Experience in embedded system hardware and/or real-time software design
Expertise in using tools such as Matlab, Visual Studio C++, Microsoft Foundation, etc

Development Scientist Resume Examples & Samples

Possession of a Doctoral degree related to life sciences from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or eight (8) years of experience in lieu of a degree
Foreign degree must be evaluated for U.S. equivalency
Cell culture experience
Expert in aseptic technique
Experience with operation of cell culture systems
Proficient in GMP production operations and documentation
Ability to work collaboratively in a multi-disciplinary environment

Systems Development Scientist Resume Examples & Samples

An understanding of Agile software development methodologies
Demonstrated ability to plan and execute work and to deliver projects on time is essential to the success of this role
Thorough understanding of the Atlassian tool suite
The developer will have the ability to translate business requirements into solutions
Must be able to work independently and as part of a high performing agile team
Familiarity with C&A processes for deployment on sensitive networks helpful

Immunoassay Method Development Scientist Resume Examples & Samples

Development of large molecule PK, ADA, and neutralizing cell-based assays with minimal assistance, as team member or project leader
Perform ELISA, MSD, and Luminex based assays, and other immunoassay techniques
Perform analysis of immunoassays using softmax pro software
Learn and perform required laboratory techniques using novel and established protocols and Standard Operation Procedures acting as team member under the direction of project leader or in role of project leader
Responsible for production and maintenance of cell lines and cell/tissue culture in cellular immunology lab
May act as project manager depending on experience
Responsible for the preparation of stock and working solutions/standards and QC samples as needed
Responsible for the documentation of all project work in appropriate laboratory notebooks
Ability to work a flexible schedule and adapt efficiently to program changes
Production of quality data and documentation
Order and stock laboratory supplies if needed
Maintenance of laboratory instrumentation and systems as required
Maintain personal training file and assists in training of other technical staff
Experience in developing large molecule PK and ADA assays in a GLP laboratory
Ability to maintain clear and efficient method development documentation
Ability to optimally maintain long-term culture as needed
Ability to develop novel cell-based assays as needed
Ability to complete documentation
Understanding of development/validation of immunoassay methodology

Development Scientist Resume Examples & Samples

Manage a group of development associates to develop and optimize cell culture processes for the production of therapeutic proteins
Support technology transfer of processes to internal and externa manufacturing sites
Lead process characterization work including risk assessment and studying the process sensitivity with respect to various process parameters and their interactions using DOE and statistical analysis
Contribute to preparation of CMC sections in regulatory submissions such as IND and BLA
Collaborate within department and cross-functionally to meet set objectives
PhD degree in (Bio) Chemical Engineering / Biotechnology / Biochemistry or related fields with 3-5 years relevant industrial experiences
Broad knowledge of cell culture process development and process characterization
In-depth knowledge of scale-up principles, scale-down models, tech transfer concepts
Strong DOE and data analysis skills, including the use of statistics (JMP or similar software)
Excellent communication and management skills

Research & Development Scientist Drilling & Completion Fluids Resume Examples & Samples

Perform research, testing, trouble shooting, and problem-solving in research environment
Assist in planning and conducting research, design and development of standard engineering assignments
Assignments will typically be a portion of a larger project
Select scientific methods and techniques to solve problems and makes sound recommendations
Assignments are reviewed for overall soundness and adherence to stated objectives
Sphere of influence limited to immediate supervisor, work group, support organizations and vendors
Bachelor's Degree in Scientific discipline and 1-3 years of laboratory, chemistry, or drilling and completion fluids experience OR Master’s Degree in Scientific discipline and 0-1 years of laboratory, chemistry, or drilling and completion fluids experience
Oilfield experience
Chemicals or Drilling Fluids
Mud School
Field experience in Drilling and Completion Fluids

Development Scientist Mylan Dublin Respiratory Resume Examples & Samples

Ensure the successful development and transfer of the commercial manufacturing process and product knowledge
Compile, review, execute and report process development and clinical protocols to assure appropriate data for regulatory submissions and compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale
Co-ordinate the compilation of technical components of the regulatory submissions
Author, and coordinate the completion of technical reports to support product submission filings
Execution of process development/demonstration or validation studies and write-ups
Process development/ design for commercial facility
Confirmation of process Technical Transfer
Micronisation process validation and monitoring
· Industrial or academic inhalation experience
Minimum BSc with very strong development skills, MSc + advantageous

Research & Development Scientist Resume Examples & Samples

Work in pilot plant and support production scale ups and commercialization
3-7 years of experience in related field of work. Preferred experience in sauces and fillings for ice creams and/or baked goods
Experience of working with sugars, sweeteners, clean label products with in depth understanding of sauce rheology and ingredient functionality
Language Skills Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization
Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Work well in an ambiguous setting, self-motivated, proactive, work with minimal direction
Work well with cross-functional teams
Communicate effectively, team player, report results in a conscience manner, stay abreast of current literature
Problem solver, solution seeker, complete given objectives, independently identify experimental work necessary to achieve project objectives, contribute workable creative ideas
Interact with other groups within Kerry when necessary(applications groups/marketing/production)
Language/Fluency: English

Senior Fragrance Development Scientist Resume Examples & Samples

Responsible for global fragrance development including developing & issuing briefs for new projects, base changes, feasibility studies, fragrance modifications, regulatory mandates
Provide input on fragrance directions based on technical and category requirements – including consumer expectations, technical/base requirements and limitations, current trends. Work with Marketing and PD to understand business objectives and resource allocation/timeline to manage fragrance development
Work with the consumer research team to develop / optimize / validate fragrance screening & selection methods. This includes sensory testing, CLT or home use testing
Oversee odor evaluations including stability, submissions, reworks, production material. Provide detailed technical & fragrance ingredient assessment
Manage external resources & communication (houses). Monitor regulatory & safety required ingredient changes and manage fragrance modification and validation for the global portfolio

Assay Development Scientist Resume Examples & Samples

Responsible for the efficient development and optimisation of study methods within the relevant group
As required, provide appropriate technical training for staff to develop their skills and the group knowledge base. Should take responsibility for technical aspects of projects undertaken within the group, maintain track of team activity and strive to keep projects on schedule
In depth knowledge of data processing systems
Comprehensive understanding of routine use and maintenance of equipment appropriate to BioCMC, including trouble shooting
To help support equipment qualification within the BioCMC Division. This may include qualification design and protocol preparation

Technology Development Scientist Resume Examples & Samples

PhD in a scientific discipline
A proven record of innovation in molecular biology protocols
Must be a highly competent investigator, able to troubleshoot and quickly solve challenges
Ability to work independently to progress projects from concept to product
Must be able to demonstrate a multidisciplinary approach to problem solving and be hands-on
Must be detail oriented and highly motivated
Solid communication skills
Ability to work within a fast paced, multidisciplinary and dynamic environment
Experience in the field of next-gen library preparation and sequencing
Experience in the use of liquid handers and sequencing instruments

Biopharma Development Scientist Resume Examples & Samples

MS/ Ph.D. in Chemistry or Life Sciences with > 3 plus years of experience at a biopharmaceutical company performing LC/MS and/or CE/MS
Extensive experience in monoclonal antibody characterization in a biopharmaceutical environment
Excellent oral/written communication and presentation skills are an absolute necessity
Experience in sample prep and method development for LCMS or CE/MS applications
Team oriented with ability to work individually
Job location in Brea or Redwood Shores, CA

Biopharma Development Scientist Resume Examples & Samples

MS/ Ph.D. in Chemistry or Life Sciences with > 3 plus years of experience at a biopharmaceutical company performing CE/MS
Experience in sample prep and method development for CE/MS applications
Job location in Brea, CA

Development Scientist Resume Examples & Samples

Degree or equivalent within Chemical, Pharmaceutical or related science (or equivalent)
Familiarity with analytical techniques such as Ion Chromatography, HPLC and other conventional analytical techniques
.Experience in developing and validating analytical methodology to support formulation development, aligned to QbD principles and ICH guidelines
Ability to apply scientific principles and techniques to assigned projects
Some working experience within a science related company
Knowledge of R&D processes and associated commercial environment
Clear communicator in both oral and written form with both internal departments and external organisations
Demonstrates ability to take initiative, think and work independently, problem-solve, work effectively in teams, and multitask
An ability to organise and report study data from internal and external sources
Basic understanding of statistics and its application to experimental work
.Familiarity with-formulation development with consumer healthcare products, cosmetics or medical devices
Manages or contributes to one or more projects in support of departmental plans. Exercises a wide degree of technical sophistication in accomplishing assigned objectives
Designs experiments and carries out scientific work with an awareness of current analytical techniques. Creates product development plans to fit overall project objectives
Maintains awareness of scientific literature to assist work progression and understanding
Maintains precise accurate experimental records; issues reports at project milestones; writes invention records to protect scientific discoveries
Sets and resets priorities to remain focused on objectives in rapidly changing circumstances
Always ensures all work is conducted following good scientific practice and where required follows Good Manufacturing Practice
Takes responsibility for specific equipment in accordance with site procedures
Produces or contributes to, departmental quality documentation (including SOP’s, batch documentation, validation protocols & reports)
Highlights own training needs and working with manager develop a training plan and achieve training goals
Trains self and others in new technology and laboratory responsibilities (including coaching, mentoring and elements of personal development)
Conducts general problem solving or lead problem solving initiatives using formal procedures
Specific safety and quality responsibilities for department and site (e.g. GMP, Audits, Health & Safety)
Responsible for the development and implementation of the technical transfer of methods or processes
Develops knowledge of regulations impacting areas of work (e.g. EP/USP/ICH)
Works with others to help facilitate completion of outsourced activities by identified contractors

Immuno Assays Development Scientist Resume Examples & Samples

PhD/Doctorate in Biological and Biomedical Sciences
5 years experience in BioPharma Industry
Experience in developing immunogenicity (both anti-drug antibody and neutralizing antibody assays) and/or biomarker assays in a GxP environment
Collaborative working - Experience of working with teams and individuals in other parts of the business in a collaborative manner to develop business solutions and create value
Good communication skills. Fluent in spoken and written English both scientifically/technically as well as conversational
Drive the immuno assays development according to the defined Analytical Target Profile through the understanding of CQAs
Scouting, refinement, development, qualification and transfer of release, stability and IPC methods
Criticality confirmation studies for quality attributes
Deliver GMP release testing methods in the field and transfer to GMP testing group in compliance with relevant Quality and scientific expectations
Drive the characterization testing of clinical and commercial products
Characterization of Phase 1-2, Phase 3
Characterization of commercial products and LCM (highly specilized platform)
Deliver the antigen and product characterization needs to other TRD functions using state-of-the-art technologies for analytics and data interpretation
Support for process understanding and testing of non GMP DS & DP
Coordinates projects and resources according to defined priorities
Plans lab activities for different projects/technologies (Manpower, logistics)
Holds responsibility of the follow-up of lab activities as referent for technician(s)/associate scientist work/activities regarding different projects and technologies
Responsible for design and execution of experiments; may actively take part in execution
Reports the results in a comprehensive form after interpretation and extensive quality check of the raw data. Defines the quality requirements. Suggests improvements and offers perspective for further developments
Writes experimental procedures and scientific reports
May be responsible for technical follow-up of external collaborations
Encourages reflection on the need to adapt or align procedures regarding the GxP/Security/QA rules application in his/her team/lab
Presents results, conclusions and perspective to technical team meetings and task forces
Ensures proactive scientific/technology watch within his/her own competency domain
Ensure scientifically correct and state of the art approaches, implements new and innovative technologies
Shares know-how in his competency domain and supports others in their development

Associate Development Scientist Resume Examples & Samples

Manage product Development, Renovation, Cost Improvement and/or Technology projects (local market, regional and global)
Design, organize and execute pilot plant trials, factory trials and start-ups
Produce prototypes samples for review or consumer learning
Represent and advocate on behalf of R&D in cross-functional Project meetings (with Marketing, Operations, and Finance)
Ensure alignment on project deliverables and timing
Previous R&D Project Management experience in new product development (min 1-2 years)
Experienced in working with business teams is an asset
Working experience in food industry and fast paced environment

Catalyst Development Scientist Resume Examples & Samples

Design and develop Catalysts/Additives for FCC (Fluid Catalytic Cracking) and similar applications
Produce catalysts on bench scale as well as in pilot facilities with desired properties and performance
Lead scale-up of catalysts and additives developed in the laboratory
Work closely with manufacturing for successful plant trials of new products
Compile comprehensive reports on additive and catalyst development
Follow commercial trials for fine-tuning and further product improvement
Develop in-house expertise in catalysis, applications, and characterization
Keep abreast of literature and patents related to catalyst formulation/materials science and characterization
Contribute to developing testing procedure and deactivation methodologies
Understand operation/manufacturing and its constraints for catalyst development
Act as a resource to others in areas of materials synthesis and characterization methods and techniques
Participate in technical and safety reviews (e.g. HAZOP) for projects
Promotes safety at the work place
Drive EHS improvements and good housekeeping, leading by example
Provides supervision for Pilot Plant technicians during catalyst development
Performs other duties as requested by management
3-5 years of applied experience in a commercial setting preferred
Experience with catalysts /additives development. FCC applications preferred
General catalysis, FCC additives and unit operation, chemical reactions, emission control additives and methodologies

Ingredient Development Scientist Resume Examples & Samples

Experimental operations, data collection/analysis, collaborations with internal/external resources, and training
Microscopy, spectroscopy, other analytical testing, along with data anlaysis and accurate reporting of results
Ingredient development will include handling and evaluating processes of food powders and other ingredients
Development of methods, SOPs and training guidelines, as well as compiling and evaluating historical data

Application Development Scientist Resume Examples & Samples

Have a deep understanding of the functional attributes of a wide range of polymers, adhesives and tackifier resins materials relevant to Eastman technologies
Translate fundamental knowledge to the development of new applications and the identification of new market platforms
Develop an understanding of end-user requirements and testing procedures to determine how Eastman product offerings can enhance adhesive applications and performance
Identify needs and opportunities through direct interactions with customers, sales and marketing teams with the ability to translate those unmet needs into differentiated new product or service solutions
Ability to work with and connect seemingly unrelated pieces of information
Translate ideas and concepts into detailed technical work plans that allow a Technician resource to safely and effectively execute process chemistry or applications development
Provide technical support for customer inquiries and complaints
Assist customers with Adhesives application development and scale up
Provide plant support for manufacturing and process optimization of existing and new products
Prepare technical presentations and supporting literature to enable customer engagement
Protect intellectual property through patent applications and communicate relevant technical data through presentations at external customers’ sites
Represent the company at industry events and other forums
Travel (up to 30% of time) to Domestic and International locations under short notice
A Ph.D. or Master’s degree in Polymer Science/Engineering, Materials Science, Chemical Engineering, Chemistry or related field from an accredited college or university
Minimum of 3 years of experience with a PhD, or 5 years of experience with a master’s degree, of industrial experience in the adhesives or polymers industries
Broad working knowledge in a wide range of polymer science skills including: structure-property relationships, polymer physics, characterization, mechanics of materials, and polymer testing
Previous project leadership in an industrial setting is preferred

Early Stage Development Scientist Resume Examples & Samples

Scientific Elaboration and Project management of phase I Translational Pharmacology / Discovery Medicine / novel biologics studies
M.S. or Ph.D. in Life Sciences with current knowlegde or experience in monitoring clinical studies
Fluent in verbal and written English, Dutch, French (at professional level)

Senior Catalyst Development Scientist Resume Examples & Samples

Plans and executes experimental programs to meet objectives, timescales and budgets
Develops new catalysts for Fluid Catalytic Cracking (FCC) applications
Coordinates and leads scale-up efforts for product launch & commercialization
Analyzes results and compile comprehensive reports
Analyzes commercial trials of new products, and fine tune laboratory procedures and methodologies to mimic commercial findings
Develops in-house expertise in catalysis, applications, and characterization
Keeps abreast of literature and patents related to catalyst formulation/materials science and characterization
Contributes to developing testing procedures and deactivation methodologies
Understands operation/manufacturing and its constraints with regards to catalyst development
Acts as a resource to others in areas of materials synthesis and characterization methods
Contributes to technical and safety reviews (e.g. HAZOP) for projects and plant expansion
Actively identifies opportunities for continual EHS improvements
Ensures compliance with EHS standards
Provides creative and innovative ideas and research designs to meet business needs
Provides supervision and train Pilot Plant technicians as required
Strong communication skills (oral, written) to perform effectively
FCC knowledge and expertise
7-10 years of applied research in commercial setting
Proven record of successful catalyst development, preferably for FCC market
Initiative, innovation and creativity to deliver research objectives
Proficiency in a broad range of techniques
In-depth recognition of IP importance and commercial value
Collaborative relationship builder
Ability to effectively transfer technology
General Catalysis, FCC additives and unit operation, chemical reactions, Emission control additives and methodologies

Vaccine Development Scientist Resume Examples & Samples

Assist in the development of new bacterial and viral vaccines for future registration as well as the development of relevant new quality control tests for new and existing vaccines
Maintain all documentation in accordance with company and relevant quality standards
This includes the production/assistance with Standard Operating Procedures (SOP), Batch Process Records (BPR’s) & Operating Instructions (OI’s), developments and updates. Depending on requirements of the project/s, you may also work on ELISA testing
Liaising with internal stakeholders regarding testing and results on a regular basis
A tertiary or equivalent qualification specialising in a science discipline (microbiology and/or immunology preferred)
Experience working within a GMP laboratory environment is highly desirable
Great attention to detail with highly developed scientific problem solving skills
Knowledge of word processing and spread sheet packages
Good communication skills with the ability to work autonomously as well as within a team

Principal Development Scientist Resume Examples & Samples

Broad-based technical leadership that spans across multiple therapeutic categories and or scientific disciplines and is a recognized expert in the scientific community
Developing and executing technical strategies across multiple therapeutic categories and/or scientific disciplines
Project Leadership of complex global projects
Makes wide ranging, independent decisions on projects and technical issues
Stays current with technologies and industry practices and applies relevant information to GSK Consumer Healthcare
Explores and identify new technologies as appropriate with the agreement of the key stakeholders and develop expertise internally
Coaches and mentors peers and other staff to develop new technical skills
Works with Manager to assess staff for potential growth for others within the organization
Communicates collaboratively and influences staff at all organizational levels with both internally and externally with specific organizations
Provides technical input and direction from a product development perspective to the Therapeutic Category Team and related functions as the expert for that category
Thinks strategically and provides recommendations and decisions which have a major impact on project plans

Senior Textile Applications Development Scientist Resume Examples & Samples

Identify unmet customer needs and market trends, and to translate those into practical new product solutions in our apparel market space
Assist the business in creating competitive advantage through with these solutions through the development of intellectual property, trade secrets, and to enable first to market incumbency
Ownership of the technology component of new innovations throughout the launch/commercialization process. Specific initiatives to include new elastic fiber developments for knitted and woven stretch fabrics and to work on product suitability and consistency for products sold into our active outerwear and sportswear marketing segments. This includes products marketed and sold under our LYCRA(R) and COOLMAX(R) brands
Responsible for providing technical support to new and existing customers by applying product and application knowledge in trouble-shooting and product qualification efforts
Work in close collaboration with Marketing and Sales organizations, supporting market launches of new product offerings through technical presentations, customer support, competitive benchmarking and analysis, and participation in framing the business opportunity for new innovations in the apparel market space
Bachelor's Degree in Chemistry, Chemical Engineering, Material Science, or Textile Science AND 5 years of experience in the textile or closely related industry OR a Master's Degree or PhD in one of the above disciplines
Ability to travel up to 20% including international travel
Experience working with customers to resolve product performance problems and to identify new opportunities to create a profitable product pipeline
Technical understanding of the synthetics fibers industry, standard fabric manufacturing processes, and a basic understanding of the apparel value chain from fiber to garment
Experience in all elements of the product development cycle, ideation, scouting, development, introduction, scale-up and commercialization of new products
Experience in designing experiments and testing programs in a safe and compliant manner

Bioassay Development Scientist Resume Examples & Samples

Develop bioassays for early through late stage clinical development programs, assisting in phase-appropriate assay qualification and transfers
Carry out characterisation testing, and troubleshooting experiments, and author/review corresponding documents
Support investigations in the contract bioassay testing labs as well as qualification of reference standards, assay controls and reagents
Represent Bioassay Development on project/cross-functional teams and coordinate development activities in support of early-stage development programs in an environment where individual initiative, collaboration and accountability are valued
Ph.D / M.Sc / B.Sc or equivalent in Biochemistry, Cellular Biochemistry, Molecular Biology, Chemistry or a related field with experience in developing bioassays
Knowledge of biochemical and analytical techniques for biologicals
Understanding of regulatory and industry guidelines in the area of potency
Understanding and technical knowledge with analytical technologies and experience in the assessment of bioassay data
Scientific background in bioassays (enzymatic, cell-based, ELISA, binding assays, etc.) and scientific knowledge of mechanism-of-action of biologics
Experience with Enzymes and Antibody Drug Conjugates
Good team player with excellent communication skills
Ability to communicate clearly and professionally both verbally and written format

Director, Clinical Development Scientist Resume Examples & Samples

PhD, or Master's degree in heath science field, PharmD, MD, or other relevant advanced degree in a health science field
Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or haematology
Two or more years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment
Immuno-oncology development experience desirable; global pharmaceutical experience
Excellent oral and written skills; strong interpersonal and listening skills
Results driven to achieve creative and sound outcomes
Proven leadership skills and demonstrated ability to interact collaboratively in a cross functional environment
Ability to make sound and timely decisions; agile in learning and action oriented
Ability to relate to colleagues and associates at all levels both inside and outside the organization
High level of emotional intelligence; able to deal with ambiguity
Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams; experience managing and developing others (Director only)
Able to act independently on most issues after getting initial guidance; will require supervision from MD's when it comes to patient safety issues and overall study conduct issues

Research & Development Scientist Resume Examples & Samples

Support product application for regulatory approvals
Help with troubleshooting problems during production and manufacturing
Ph.D. degree in biology preferably genetics, molecular genetics or a discipline related to molecular diagnostics, is required
Mandarin Chinese: spoken, reading and writing skills equivalent to master degree; English: fluent listening, reading, written, speaking is required
Analytical and quantitative skills equivalent to a master degree; trend charting, graphical presentation, statistical analysis skills and spreadsheet design are required
Excellent organization and interpersonal communication skills
Ability to think in a rational, logical manner
Competency in MS Office required (Word, Excel, Outlook and PowerPoint)
Understanding or experience with an ERP systems is desirable
Ability to lift a minimum of 30 kilos to waist level at 5 times consecutively; ability to move a minimum of 50 kilos a minimum of 25 meters is required

Upstream Development Scientist AS Resume Examples & Samples

You will have to be educated at degree level in bioengineering, chemical engineering and microbiology
Upstream process experience gained in similar environments
Considerable hands-on laboratory experience (ideally within a biopharm setting)

Research & Development Scientist Resume Examples & Samples

Development of high-performance mass spectrometric instrumentation and related technologies in a highly motivated multi-national multi-disciplinary team in Bremen, Germany
Execution of feasibility experiments to show the proof of principle of new development ideas
Participation in product development projects
Development of system requirements specifications for a new product in cooperation with product marketing
Guidance of mechanical and electrical engineers by developing sub-system requirements specifications
Practical and theoretical characterization of newly developed instrumentation
Creation of verification test plans and test summary reports
Knowledge transfer to manufacturing, product support and field service on newly developed instruments or components
University degree in physics, engineering, chemistry or related science, or equivalent education and work experience
Several years of proven experience in development of complex analytic instrumentation, preferably in the field of mass spectrometry
Programming skills in a major programming language or scripting language
Strong desire to push the limits of science and technology
Fluent in English, willing to learn German
Good communication and teamwork skills

Development Scientist Resume Examples & Samples

Bachelor’s degree in Chemistry with 0-2 years of relevant scientific experience
Experience with general organic chemistry research techniques
Experience with statistical software is a plus
Experience with work productivity software (MS Office)

Immunoassay Development Scientist / Engineer Resume Examples & Samples

Lead immunoassay development and standardization activities. Oversee activities from feasibility through analytical and other pre-clinical studies to support regulatory submissions
Assign, direct and evaluate the work of laboratory/research personnel; also oversee the development and maintenance of staff competence
Execute development activities to insure robustness of the assay on the OPKO microfluidic platform. Interface with engineering and production staff to insure reliable transition to pilot manufacturing
Select/prepare biological reagents, develop QC methods, and support management of critical suppliers within the OPKO Diagnostics supply chain
Assist or lead in the generation of Quality System documentation and approval activities (including: Design Input/Output, Specifications, FMEA, and Design History Files), participate in design review meetings as a key contributor, and assist in the submissions and review of responses to notified bodies and federal agencies relative to medical device directive compliance
Interface regularly with manufacturing team, QC and QA to facilitate transfer of assay to manufacturing, contribute to generation and approval of technical documentation

Research & Development Scientist Resume Examples & Samples

Design, develop, verify, and validate new lateral flow drugs of abuse immunoassay products in urine
Conduct complex experimentation including data collection, summary and thorough analysis, in support of department research projects and guidelines. Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimum information
Solve complex problems that arise throughout the design and development of the product
Maintain records of laboratory activities and notebooks in a professional, accurate manner. May provide support to regulatory and intellectual property activities
Mentor and coach R&D staff, as well as train members of other departments when transferring technology
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

India Tech Service & app Development Scientist Resume Examples & Samples

Lead pharmaceutical formulation/applications projects in the area of oral applications and drug delivery systems for global and local market standards
Plan formulation projects, design and conduct experiments, analyze results
Maintain accurate records of experiments, results and conclusions
Provide projects updates through issuance of technical reports and presentations for internal and external use
Use expertise and knowledge to promote Lubrizol technologies to accelerate product development
Work seamlessly as a member of and LLS global technical organization and local LLS cross-functional team
Conduct work within Lubrizol laboratories, in compliance with all safety policies and procedures

Clinical Development Scientist Resume Examples & Samples

Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution
Expertise in infectious disease and/or transplant preferred
Experience in rare diseases desired
Demonstrated understanding of drug development and pharmaceutical marketing within

Application Development Scientist Resume Examples & Samples

Help identify new product or application opportunities for compounded thermoplastics
With customer interactions and internal collaboration determine fitness-for-use (FFU) criteria for specific applications
Reduce the FFU criteria to fundamental polymer formulation characteristics using knowledge of polymer processing-structure-property relationships
Generate technical and processing appoaches that stand the greatest likelihood of meeting customer unmet needs
Develop project plans, design and execute experiments to test critical FFU criteria and commercial feasibility of concept
Identify applications testing equipment to enable rapid prototyping and quickly move projects to commercialization
Communicate results and recommendations to team and management; document results in reports; active in intellectual property generation
Apply statistical tools effectively (six sigma, design of experiments)
5+ years experience in thermoplastic polymer product development required
Experience in twin screw extrusion required
Experience in thermoplastic polymer formulating required
Experience with polymer blends preferred
Familiarity with polyester thermoplastics preferred
Excellent oral and written communication skills to work in a team environment

Clinical Development Scientist Resume Examples & Samples

Bachelors degree in Biomedical or Health Care related specialty; advanced degree preferred (e.g. PhD, PharmD)
Demonstrated experience in clinical research and the design and conduct of clinical studies, including knowledge and understanding of ICH/GCP guidelines and SOPs
Strong scientific background; good knowledge of basic or clinical immunology preferred
Flexible, focused, enthusiastic, self-driven and highly motivated
Maintains a disciplined approach, ensuring a relentless focus on detail, quality, compliance and operational excellence
Excellent interpersonal skills and experience of working collaboratively with teams in a matrix environment across functional and geographic boundaries; understands the necessity of a strong partnership with colleagues (e.g. Clinical Operations, Regulatory, Safety)
Able to prioritise effectively, and rapidly assimilate information from a disparate range of sources
Proactively identifies problems and recommends solutions
A proven ability to deliver clear and effective scientific messages both orally and in writing
Clinical research expertise and experience in the early phases of drug development preferred
Ideally sound knowledge of the immuno-inflammatory therapeutic area
Has experience in the successful design and conduct of biomarker-focused experimental medicine studies
Develop scientific expertise on the clinical development for assigned compounds
Lead or contribute strategic input to the clinical development plan
Key contributor into the translational package / biomarker strategy for a compound
Act as the clinical representative on Study Conduct Teams to ensure the clinical/scientific integrity of the study, and that trials are conducted effectively within budget- and time-constraints in order to deliver submission-quality data
Develops and writes relevant sections of clinical documents such as study protocols, study procedure manuals, patient informed consent, written responses to IRB/Ethics Committees, clinical study reports and scientific publications
In partnership with the Medical Monitor, provides clinical protocol training to internal and external groups (including at Investigator Meetings)
Support of regulatory interactions (e.g. contributing to the creation of regulatory documents such as Investigational New Drug / Clinical Trial Applications, Regulatory Briefing Documents, and Investigational Brochures, support/attendance at regulatory meetings as required)
Key contributor to the review of study data, interpretation of results and internal / external communication of study conclusions
Actively engages and integrates external academic and clinical trial expertise and resource to enhance quality and delivery of experimental and clinical development trials
Drive presentation and publication of clinical and scientific outputs
Work with and provide clinical support to the global clinical matrix teams, including late stage clinical development, regulatory and commercial experts, to deliver the overall needs of the medicine development strategy
Must be able to manage and influence effectively across multiple geographies, cultures and time-zones in a matrix environment
Must be able to interface seamlessly with other functions and groups within GSK, as well as external regulatory agencies to advance clinical assets effectively
Must be able to ensure alignment of Clinical Strategy for external collaborations

Senior Development Scientist Resume Examples & Samples

Identify and evaluate, via a range of lab-scale material synthesis techniques, product development opportunities within the layered nickel oxide space; emphasis on formulations including manganese
Formulate detailed process parameter/structure/property relationships that can be used to advise product scale-up, including being a key technical contact during the product development cycle
Drive continual improvement in lean product development methodology
Interface with commercial, legal, process scale-up and complementing cathode development teams to make informed strategic recommendations about product development opportunities
Reproducibly process materials for electrochemical testing. Subsequently, critically assess electrochemical performance, using results to feedback into optimisation of synthesis parameters
Support customer programmes and related technical engagement on request
PhD in Chemistry or a related subject; alternatively, demonstrable experience in related field
Experienced in the synthesis and characterisation of mixed metal oxides, preferably Nickel-based
Experienced in critically assessing and optimising the electrochemical properties of secondary battery materials, preferably lithium-ion based
Demonstrated product development experience, including assessment and filing of Intellectual Property documents, managing upwards on ideation/opportunity identification and scaling from lab to larger powder volumes
Demonstrated attention to detail and an ability to work to tight deadlines
Ability to travel domestically and internationally

Analytical Development Scientist RA Resume Examples & Samples

Educated to degree level in one of the life sciences subjects, preferable in biological subject
Some knowledge of analytical testing requirements of biological manufacturing processes, as well as analytical development of methodologies used to test biological products
Knowledge of ICH guidelines and experience in analytical validation (desirable but not essential)
Multi-task, team player with good organization, record keeping and communication skills
Some knowledge and experience of good experimental design and statistical analysis
Some knowledge and experience of manufacturing and/or laboratory practices and quality systems

Associate Technical Service & Development Scientist Resume Examples & Samples

Effectively implements new technologies, products, or applications to address technology needs for the business. Comprehends test method scope and limitations and prepares internal test methods, designs overall testing protocol to deliver project objectives
Consistently applies the scientific methodologies to solve technical problems while working in the R&D Laboratory to design new formulations and develop innovative technologies to bring enhanced performance features to customers, e.g. thermal insulation and productivity improvement. Understands and efficiently use the connections of the scientific method to NPI and other methodologies such as Six Sigma, ICO and DFSS
Develops new approaches and solutions to problems by considering issues from different points of view, supports active and new customers in all technical tasks, develop and support joint technical projects with customers to increase value to Dow, being the interface between internal Dow departments and the customers
Manages secrecy agreements and joint development agreements to protect Dow technology for specific projects, leverages technology development within EMEAI region and globally when needed
Provide constructive input to project participants, build technical relationship with customers providing PU performance trials to meet application performance requirements
Leads technical sub-teams and defines scope of the larger project space, actively work in team with Marketing and Sales communities to drive the implementation of enhanced products and technologies
Deliver presentations or reports that distill complex ideas into clear results and proposals; communicates appropriately to influence internal and external audiences
Communicate and appropriately document work in the form of internal reports ROC's/presentations, technology manuals, knowledge management resources, CRI’s, external reports, and patents when appropriate
Partners with Product Stewards to identify and address regulatory constraints and requirements for implementation of product strategies through in-depth knowledge of applications
Manages the technical projects for a business within a geography. Translates competitive knowledge into useful insights for internal stakeholders and works closely with marketing to proactively lead effort to identify new high-value opportunity spaces with internal and external stakeholders
Identifies market needs and potential solutions and works with immediate work group to initiate projects to address. Anticipates technical requirements, trends, issues and competitive response to identify highest value and highest success technical opportunities
Provides effective TS&D to numerous strategic accounts for the business and responds to technical questions of customers and other Dow/market-facing businesses
Monitors the competition and market trends relative to Dow intellectual capital positions and integrates the information into group activities and projects
Manages tech service for Dow customers including PU trials execution, trials follow up and technical meetings, new technology implementation, high level meetings with customers’ key decision departments
Demonstrated ability to effectively implement new technologies, products or applications to address technology needs for the business
The role requires motivation, high initiative, problem solving, good scientific methodology and project management skills as well as the ability to work successfully in varying environments and in teams. Excellent communication skills and the ability to cooperate closely with customers and across internal functions are essential. A passion for technology and the high affinity to understand customer needs and application requirements are of key importance
Ability to successfully partner with team members and stakeholders (sales, marketing, TS&D, R&D, regulatory, product stewards, etc) from multiple backgrounds
Excellent verbal and written communication skills. Networks within Dow and the industry to position Dow as technology leader and achieve business results
Has contributed to Dow's profile through numerous publications and contributions to conferences and customer seminars
Strong knowledge of material creation process, raw material/product registration process, industry EH&S requirements
Previous experience in Polyurethane TS&D or R&D or equivalent industry experience
Previous experience within business or in related business
Six Sigma Green Belt Project Leader Certification

Senior Research & Development Scientist Resume Examples & Samples

Integrate data from new sensor technologies into analysis process
Ensure deadlines are met in a fast-paced multi-disciplinary environment
Develop automated techniques as per standard process
Ensure proper documentation is maintained
Graduate degree in Engineering, Physics, Math or equivalent
3 + years of experience in a R&D environment or related fields
Computer programming skills and experience with MATLAB or other mathematical software experience
Analytical skills, modeling skills and statistical knowledge
Project management experience managing budgets, timelines and small groups of individuals
Ability to work in small teams and independently with minimal direction
Pipeline inspection experience

Research & Development Scientist Resume Examples & Samples

Develop new or optimize existing algorithms for identification and estimation of detected features
Develop and maintain processes to ensure data accuracy and integrity
Bachelor degree in Engineering, Physics, Math or equivalent
1 + years of experience in a R&D environment or related fields
Computer programming skills and experience with MATLAB, C, C++, or R or other mathematical software experience
Effective communication skills verbally along with technical writing and documentation experience
Candidate with a Master’s degree in related field and experience will be an asset
Experience in regression and optimization, image processing or image analysis is desirable

LC / MS Methods Development Scientist Resume Examples & Samples

Experience and knowledge of analytical instrumentation (eg – HPLC, GC, LC/MS/MS)
Highly skilled in performing scientific presentation and preparing scientific publications
Knowledge of laboratory automation software, system software, and Microsoft applications

Analytical Development Scientist Resume Examples & Samples

Development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories
Support establishing internal laboraties for analytical development for T-cell therapy products
Own and manage analytical methods lifecycle during clinical development. Work with colleagues in validation and QC for post approval analytical life cyle management and alignment with continued process verification plans
Contribute to product specification development
Partcipate in risk assessments to develop robust product control strategies for cell/gene therapy programs
Responsible for management and successful closure of investigations
Responsible for delivery of relevant sections of regulatory filings and responses to regulatory questions
Support capability build in other functional areas as needed
Responsible for successful interactions with contract manufacturing at third party manufacturers and testing laboratories. The role requires significant external engagement with 3rd parties (contractors, suppliers, testing laboratories, academic and industry groups)

Research & Development Scientist Resume Examples & Samples

Responsible for the development and validation of analytical procedures used to analyse drug substances and drug products as well as the transfer of these procedures to the various sites. Responsible for re-evaluating, optimising and troubleshooting methods as required by clients
In addition responsible for providing guidance to and overseeing analysts within the Analytical Operations regarding the performance of their activities related to department
Follow Training SOP for training and training records
Provide technical support and feedback to clients and other SGS groups
Perform the development and validation of analytical testing procedures for drug substances and drug products
Write protocols, drafts methods and technical reports for the Research and Development department and clients
Executes experiments, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines
Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in timely manner
Write and Review technical data, documents, SOPs and proposals as required
Coordinate method transfers between clients, the Research and Development group, and the RM/Finished Products departments
Assist in the failure investigations within other SGS groups and design investigation protocols and suggest corrective actions
In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate
Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the QA reviewer
Participate in training sessions in the proposal, investigation and introduction of new technologies and services for SGS
Ensure that equipment is maintained properly. Also perform calibrations and qualifications as required
Ensure that equipments are maintained in a good order, calibrated and qualified as required
Keep the work area clean and organized; immediately clean up spills, dispose of waste according to laboratory procedures and place used glassware in designated locations for cleaning
Oversee, train, mentor and guide Analysts/Scientists in their work
Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory
Perform other assigned lab duties as requested
Education: BSc or MSc/PhD
Experience: 5+ years with demonstrated ability to complete more complex role/duties
Hand/Eye coordination, ability to stand out, think outside the box
Able to read, understand and follow work instructions in a safe, accurate and timely manner
Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook)
Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment
Ability to work well with others & independently
Extended hours and shift work may be required from time to time
Travel to other SGS locations or client location may be required from time to time or lead a group of individuals at Client’s site

Color Development Scientist / Engineer Resume Examples & Samples

Responsible for new color product development in all Celanese EM resins systems including ETPs, TPEs, and some amorphous resins. Development efforts may include color formulation development, stabilization development, product additive enhancements, polymer modifications, and compounding process improvements
The individual will be responsible for gathering technical needs from customers (internal and external) to enable them to develop products which meet or exceed requirements. Projects are aligned with growth initiatives and market needs serving automotive, appliance, consumer, electrical/electronics, medical and other markets and applications
This job will require close collaboration with Customers, and internal Program Management, Commercial Teams, Manufacturing and other Technology & Innovation functions
Responsibilities include working closely with colorant, additive and equipment suppliers to stay current with state-of-the-art technologies
The individual is expected to grow and advance within the Celanese career ladder
Demonstrated industrial track record of commercialized color/appearance technology-based ETPs, TPEs or amorphous resins
Demonstrated expertise in plastics color chemistry including relative performance of common pigments and dyes, potential interactions of colorants with resins and additives, and other usage concerns/restrictions
Demonstrated understanding of plastics color theory including spectrophotometry, light sources, and color difference measurements
Must possess normal color vision
Ability to travel (up to 25%)
Ability to manage multiple projects
Experience with ETPs including acetal, polyester, and nylon resins, and unfilled, reinforced and impact modified versions of each
Experience with TPEs, polypropylene and common amorphous resins
Familiarity with regulatory approval processes including FDA, NSF and UL
Experience/expertise in injection molding and part appearance problem solving techniques
Experience/expertise in plastics UV stabilization technology and UV testing methodologies
Experience/expertise in general plastics stabilization and additive technologies
Experience/expertise in polymer product development processes
Trained/experienced in Design For Six Sigma (DFSS) product development process
Demonstrated cross-functional leadership skills
Proficiency in statistical techniques such as Design of Experiments (DoE)

Analytical Development Scientist Resume Examples & Samples

Support the development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories
Work with colleagues in validation and QC for post approval analytical life cyle management and alignment with continued process verification plans
Support analytical testing for process and formulation development studies
Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs

Development Scientist Resume Examples & Samples

Both directed and un-directed laboratory work
Design of experiments and studies
Analyzing results
Cell culture maintenance
Effective use of laboratory instrumentation and equipment
Written documentation
Maintaining knowledge of industry principles and advancements
Teamwork oriented with willingness to take on tasks outside of role
Demonstrated understanding of appropriate laboratory skills for pipetting, microscope use, freezers, incubators, bio-safety cabinets, titration/dilutions, and analytical instrument use
Strong academic background in biology and/or chemistry
Understanding of product development process
Engineering bias to create comprehensive product definition that encompass both consumable and packaging
Familiarity with consumable manufacturing a plus
Excellent technical communication skills, both verbal and written

Analytical Development Scientist Months FTC Resume Examples & Samples

May mentor and provide bench supervision of junior scientists or associates to support the development of analytical techniques to support strain development activities, in a time sensitive environment
Be able to handle challenging tasks to develop new analytical methodologies and optimise/improve existing methodologies
Maintain awareness of new technologies, current industrial technical and scientific literature. Selection and development of new techniques within the team to further develop in-house technology
Provide technical support to production, quality control and quality assurance groups during investigations
May represent the company at regulatory inspections (including FDA & MHRA) and respond to questions
May prepare, provide information or review regulatory documentation to support company responses to any requests from regulatory agencies
To have a minimum of a life science degree, preferable in Biochemistry, Microbiology, Molecular Biology, Virology or other science related field, as a minimum
Considerable experience and knowledge of analytical testing requirements of biological manufacturing processes, as well as analytical development of methodologies used to test biological products
Considerable knowledge of ICH guidelines and experience in analytical validation
Multi-task, team player with excellent organization, record keeping and oral/written communication skills
Knowledge and experience with analytical testing requirements of biological manufacturing processes
Knowledge of GMP, in particular manufacturing and/or laboratory practices and quality systems

Applications Development Scientist Resume Examples & Samples

This position is responsible for new idea evaluation, laboratory setup, development or improvement of gas applications, comprehensive technical documentation and offering packages, technical publications, customer demo trials, and implementation of successful solutions at customer sites
Examples of gas applications in food/beverage processing may include fast freezing, mixing/chilling/cooling, packaging, dispensing, inerting & blanketing, and grinding
Generate and evaluate innovative ideas of industrial gas applications in the market segment of processing and preservation for food/beverage products. Build a healthy long-term pipeline of technology development to differentiate company in the marketplace
Plan and execute application development projects. Use scientific principles in industrial gases and food processing to invent attractive technology that differentiates our offerings in the market place. Effectively leverage internal and external resources to speed up the progress and achieve short-term technical and business goals
Work closely with commercial technology, marketing, and business teams within Asia region for new application ideas and improvements of existing offerings
Support market promotion, identify opportunities for penetration into key customers and commercialization of existing technology to compete/win/retain gas business
Establish technical collaboration and networking with top food companies. Develop a close relationship and high reputation within the Asia food community (industry, research institutes, associations, government)
Present technical papers in related conferences or magazines and support market promotion and technical branding
Set up and upgrade Asia Food Lab to support development efforts and customer demo trials
Work closely with global counterparts for transfer and localization of application offerings and best-known practices to benefit Asia business

Formulation Development Scientist for Tox & FIP Studies Resume Examples & Samples

Preparation of prototype formulations (solutions, suspensions, tablets, capsules, etc.) for exploratory studies in in-vitro and in-vivo models. This includes development of oral, topical and intravenous (sterile) dosage forms
Measurement of key active compound and formulation properties (such as solubility,tablet hardness, disintegration, pH, isotonicity, color, gelling tendency, etc.)
Assessment of the performance of prototype formulations using in-vitro tests (non-sink dissolution, precipitation, etc.)
Development of protocols for preparation of formulations at preclinical and clinical study sites
Routine preparation of solution and suspension formulations for use in preclinical studies
Shipment of samples to study sites
At least one year experience in formulation development

100

Formulation Development Scientist Resume Examples & Samples

Responsible for task-oriented activities associated with Biologics formulation development and their analytical characterization
Characterization of various prototype formulations using biophysical techniques
Design, schedule and conduct experiments
Cross-functional interactions primarily with analytical team to understand and interpret data
Conduct data review, write technical reports and present developmental findings/milestones
Strong computer, laboratory, experimental, data analysis, and documentation skills
Ability to learn new techniques, perform multiple tasks simultaneously, prioritize, keep accurate records, follow instructions, and comply with company policies
General understanding (working experience Preferred) of ICH, EMA and FDA guidelines for conducting stability and forced degradation studies of biologics drug substances (DS) and drug products (DP)
General understanding (working experience Preferred) of biochemical (e.g., IEF, CE-SDS, SEC, IEX, HIC) and biophysical (e.g., UV, DLS, DSC, Fluorescence, viscosity, particle sizing) techniques used to characterize biologics DS and DP
PhD in biochemistry or related discipline with at least of 1 year of industry or post-doctoral experience
Or MS in biochemistry or related discipline with at least 2 years of industry experience
Or BS in biochemistry or related discipline with at least 5 years of industry experience

101

Analytical Development Scientist Resume Examples & Samples

Development of analytical method and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories
Support establishing internal laboratories for analytical development for stem cell and T-cell therapy products
Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products
Own and manage analytical method lifecycle during product development, including risk assessments and preparation of qualification reports
Support colleagues in QC and Validation and Life Cycle Management for post approval analytical life cycle management

102

Principal Method Development Scientist Resume Examples & Samples

Provide analytical support for nonclinical studies under FDA GLP’s (21CFR58), including dose formulation analysis (concentration and homogeneity) and dose formulation stability
Perform HPLC analytical method development and validation
Interpret and review chromatographic data using software systems such as Waters Empower 3
Review and verify notebook documentation
Assume responsibility as a Contributing Scientist/Principal Investigator or Study Director for nonclinical studies as required
Write protocols and technical reports as required
Interface with BI NDS study directors, Quality Assurance auditors and other MAS scientists as needed
Provide analytical support for other non-routine tasks and formulation development activities requested by NDS or MAS
Utilize and perform other analytical techniques (SFC) as needed
Minimum qualifications of B.S. or B.A. in Chemistry, with 7-10 years’ industry experience working in a GMP/GLP environment with understanding of the requirements of instrument validation in a regulated pharmaceutical environment (21 CFR Part 11 compliance and risk based approach)

103

Application Development Scientist Resume Examples & Samples

Develop integrated application solutions for global inorganic markets using ICP-MS based technology, including sample preparation, method development, application development and related consumables kits
Lead strategic technology evaluation activities and provide technical assessment to the ICP-MS product manager, assist the ICP-MS product manager to formulate and drive application, product and technology roadmap
As a BU team member to identify key application topics according to customer requirements and market trend and deploy the solutions after development
Be a global application harbor across different teams. Work closely with regional product specialists across the world and manage the application library to better support both the commercial team and customers
Provide technical support to key sustaining engineering projects to deliver fast response to urgent field case or opportunity. And act as consultant as required to R&D team and operation team
Understand the regulatory framework regionally and identify opportunities to gain regulatory penetration, both in terms of representation on panels and new methods. Gain insight into regulatory trends and timings
Be flexible to perform other related duties as assigned

104

Application Development Scientist Resume Examples & Samples

Develop project scope and perform routine laboratory work and record raw data/results as required
Analyze and interpret experiment data, communicate with team members and collaborators on working progress and make appropriate reports
Perform trouble shootings and problem solving when needed
Develop future ‘market-ready’ products for commercialization
Attends technical training and scientific meetings to gather information on new trends, products and discoveries

105

Development Scientist Resume Examples & Samples

Small to medium scale fermentation: bacteria and yeast
Experience in various biochemical methods: SDS-PAGE, Western blot, ELISA, column separation methods: gel filtration, ion exchange, affinity chromatography
Basic molecular biology: PCR, DNA miniprep- advantage
Fluent English speaking/ writing capability
Experience in the industry, Working in a regulated environment-advantage

106

Senior Applications Development Scientist Resume Examples & Samples

Serve as a technical expert for plasticizer formulations and uses both for customers and internal partners and will be expected to conduct/oversee laboratory work to develop basic knowledge to support new business opportunities
Identify needs and opportunities through discussion with customers, sales and marketing personnel with the ability to translate those needs into innovative product solutions
Lead multidisciplinary new product development project teams
Communicate results through effective written documentation and oral presentations
Travel for customer interactions and technical conferences
5+ years of industrial product development experience is highly desireable
Track record of innovation is highly desirable
Experience with plasticizers, PVC, PVB, and vinyl acetate emulsion polymers and/or additive systems for PVC formulations is strongly preferred
Broad interests and willingness to take on relatively undefined challenges

107

Field Development Scientist Resume Examples & Samples

Plan, establish, manage, and report scientific trials based on developed protocols
Utilize the various programs and management systems including data accumulation, budget, time tracking, and reporting to ensure efficient and transparent operations
Develop a network of cooperators, thought leaders, and customers to aid in conducting trials in assigned territory
Develop effective relationships with external customers, cooperators, internal stakeholders particularly area sales managers and Field Development team members is a key success factor for this role
Develop a clear understanding of development objectives and business rational for planned trials. Effective communication is critical with excellent presentation skills and the ability to simplify complex concepts
Collaborate with product development managers, marketing, and commercial operations on technical positioning based on trial results and customer needs is important in this role
Remain organized and self-directed as this is a remote role with the expectation that projects are organized and completed in a timely and professional manner
Be responsible for the field safety handling and storage of pesticides and equipment along with first aid practices and proper maintenance of equipment to insure a safe environment to accomplish field trials
Maintain a safe driving record and a high level of ethical and corporate policy compliant behavior
Understand and comply with state and federal pesticide regulations
Residence based in Texas, preferably near a major airport
Must be able to travel up to 70% of the time in the South Central US territory
M.S. degree with (5) five years’ experience having a focus in agricultural or biological science
Proficient at standard computer software (Microsoft word, PowerPoint, and Excel), able to compile, summarize and publish research material in electronic format
Be able to learn and utilize trial management and company data base programs for tracking and summarizing results
Field trial experience including use and calibration of standard application equipment, plot design, summary across trials, and safety measures
Ability to build collaborative, trusting relationships with team members
Organization including ability to work independently and without supervision, effectively plan and execute activities, complete assigned projects, accountable for work completed
Has developed a broad range of human relation skills to enable interaction with key university researchers and influencers yet communicate effectively at a practical level with customers
Ph.D. with (3) three years’ experience having a focus in agricultural or biological science

108

QC Analytical Development Scientist Resume Examples & Samples

Develops assays using flow cytometry
Assembles data and writes development reports
Develops qualification and validation protocols
Author and review protocols to analyze process improvement
Execute validation protocols as needed
Perform statistical analysis of results
Investigation of existing technology (internal and with external partnership opportunities)
Participates in the development and improvement of QC assays
Participates in tech transfer of QC assays
Execute testing procedures for all batches produced

109

Method Development Scientist Resume Examples & Samples

Conducting and overseeing LC-MS/MS method development projects
Communicating with Clients at a high level on bioanalytical science and strategy
The post holder may also be expected to provide bioanalytical leadership and have significant experience in developing junior staff

110

Fiber Development Scientist Resume Examples & Samples

Develops scientific technology platforms and products specifically related to hollow fiber development
Prepares patent disclosures, journal publication submissions, and presentation abstracts. Assists Patent Lawyers with development of patent documentation
Plans, coordinates, tracks and executes well-defined, short-term and long-term R&D project(s)
Designs and conducts experiments and engineering studies to broaden the fundamental understanding of Fiber Membrane production and processes
Participates in cross-functional teams on new product development and manufacturing problem-solving efforts
Keeps familiar with current scientific technology in fields relating to company products
Contributes to the generation of ideas and potential inventions to be use in new products
Hands-on involvement with fabrication and processing
Maintains good documentation practices for all data forms, protocols, reports, and laboratory notebooks
Understands the theory behind instrumentation and function of company products, and develops new techniques and test methods
Develops qualification test plans
Develops detailed engineering specifications
Writes Standard Operating Procedures and performs validations on test methods
Sets up, adjusts, and operates equipment and analysis instruments
Maintains general housekeeping of working area and plant
Regular attendance and maintaining a good attendance record is an essential function of the job
Builds productive working relationships
May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor
May refer to senior level staff for assistance with higher level problems that may arise
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience
Must be familiar with FDA/ISO Design Control regulations and their application
Must have good knowledge of chemistry and biology
Must have good understanding of Dialysis technology
Must understand analytical instrumentation and theory
Self-motivate to improve knowledge related to research projects by continuous assessment of current publications
Proficient with PCs and Microsoft Office applications

111

Research & Development Scientist Resume Examples & Samples

Develops, optimizes and characterizes cell culture process for the production of MAbs and other biologics
Develops new cell culture growth and feed media formulations
Bioreactor process scale-up to 60 L
Transfers processes to the cGMP plant and supports cGMP manufacturing at up to 2500L scale
Ensures that all work is properly documented and suitable for regulatory submission
Requires a PhD in life science or related field and a minimum of 2 years of relevant experience or equivalent combination of education and work experience
Ability to motivate personnel to work effectively and efficiently
Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluations
Ability to maintain extensive working knowledge of current procedures within molecular and cell biology, biochemistry, and animal modeling
Computer literate and proficient in MS Word, Excel and other relevant electronic systems
Excellent problem solving skills as well as time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
Ability to work flexible and at times, extended hours to meet business needs
Completing the online application fully
Providing all requested supporting materials with your application
Applying to positions that strongly match your experience, education and skills

112

Specialty Lubricants Development Scientist Resume Examples & Samples

Project definition, lab development, scale-up, translation of customer needs to product recommendations and new product development
To identify and understand the end use application needs, working closely with the sales and marketing functions and with the rest of technical community (R&D and TS&D, Technical Service and Development)
To translate identified needs into product and application development opportunities
Define and conduct research across multiple project areas using in-depth knowledge and proactive application of scientific principles, theory and experimental design with working knowledge in multiple disciplines
Develop and implement technical solutions through hands-on experimentation/problem-solving for research problems that are well defined across multiple project areas
Apply scientific knowledge, technical skills, and leadership to deliver high quality scientific results that are aligned with R&D project plans and create value for Dow
Demonstrate expertise in use of experimental/computational/theoretical methods and data handling
Participate in the innovation process as it applies to your specific projects and contributing to the innovation process through new opportunity identification
Consistently apply the Scientific Method in the planning and execution of experimental plans and problem solving. Formulate hypotheses and develop experimental plans to test hypotheses. Leverage Six Sigma tools and methodology to solve complex problems with projects of regional or global scope
Keep current with developments in relevant area of technology and identify and implement applications which will benefit Dow. Have an in-depth understanding of the patent and journal literature across related areas of technology. Understand and incorporate the competitive landscape in technology mapping. Work with legal department to manage IP and secure freedom to practice and patent new technologies
Serve as Subject Matter Expert (SME) or project leader on large multi-disciplinary project teams to collaborate, provide technical input and deliver results aligned with team deliverables
Serves as the Enviroment Health & Safety (EH&S) advocate for work group, ensuring understanding and adherence to policies and procedures. Leads team in promotion of best safety practices, habits, and behaviors
PhD in chemistry, industrial chemistry, material science, chemical engineering or material engineering
English and Germany language both oral as written
Minimum 3 years of experience in an industrial R&D/TS&D position
Experience in lubricants (synthesis/characterization) and/or formulation science is a plus
Experience in coatings is a plus
Experience in triboloby and tribological test methods is a plus
Ability to work in international teams, communicate and build networks across geographies and cultures
Willingness to travel nationally and internationally, up to 10%
Strong desire to develop operation skills (from laboratory scale to large-scale prototyping in dedicated facilities) , grow professionally and deal with complex work challenges
Knowledge of design of experiment techniques and/or statistical analysis, e.g. JMP software tools
A track record of documentation. Documents work internally in quality Central Report Index and Reports of Call. When appropriate, publishes research outside of the company in a manner and timing which is consistent with capturing and protecting its value for Dow
Ability to work independently and drive projects to completion. Demonstrates significant involvement in designing studies, carrying out experiments, interpreting data, etc. to meet project milestones
Strong interpersonal and leadership skills. Ability to affect cultural change

113

Analytical Development Scientist Resume Examples & Samples

BSc in biology, cell biology, virology, biochemistry or related scientific discipline
Experience in analytical method development/validation for vaccines, biopharmaceutical or cell and gene therapy products
Strong organisational and excellent interpersonal communication skills
Demonstrated excellence in technical writing skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Demonstrable ability to work independently, influence others and lead a project or team
Advanced degree in biology, cell biology, virology, biochemistry or related scientific discipline
Experience in analytical development in support of recombinant viral vector production and T-cell therapies
Experience in the development of molecular biological methods (e.g. qPCR, ddPCR) to characterise viruses and cells
Experience with establishment and oversight of development and testing at an external organization
Experience working with 3rd parties and developing/maintaining working relationships with these partners is critical
Experience leading investigations into out of specification, out of trend or process deviations including root cause analysis, impact assessment and development of appropriate corrective and preventative actions
Experience generating regulatory documentation
Demonstrated experience in analytical method transfers and control strategy development
Support establishing internal laboratories for analytical development for T-cell therapy products

114

Director, Clinical Development Scientist Resume Examples & Samples

Supporting the tactical execution of clinical protocols by working collaboratively within clinical trial team(s) including clinical development physician, Clinical Operations, Biostats, Translational, PK, and Regulatory
Assisting in the development of key documents to support the components of regulatory submissions (i.e. clinical sections of INDs, IBs, responses to regulatory queries, IMPDs etc)
External Collaboration, to obtain external scientific and clinical validation of clinical research protocols by establishing links with outside experts, including Key Opinion Leaders (KOLs)
PhD, or Master’s Degree in Health Science field, PharmD, MD
Significant global pharmaceutical/biotech or CRO Clinical or research experience and a thorough knowledge of approaches to early clinical development (Phase I through to Phase II)
Demonstrated ability to design and/or conduct of clinical studies in oncology and/or haematology
Well versed in the development of clinical protocols and making amendments
Demonstrated knowledge of regulatory filings required for clinical development (pre-IND, IND, CTD, Annual updates)
Able to relate to varied level audiences across the organisation
Skilful in negotiating organisational boundaries and hierarchy
Able to build effective teams, set priorities and maintain accountability
Experience managing and developing others
Other relevant advanced degree in a health science field
Immuno-oncology development experience
Later stage clinical development experience (Phase III – IV)
Clinical experience with large molecule/biologics

115

Research & Development Scientist Resume Examples & Samples

Designs and performs research studies to support moderate to high complexity research & development projects
May be lead scientist on challenging projects with some functional supervision
May participate in customer/vendor interface
May work closely with sales to help support customer
Helps develop new methods and products
Must be safety focused with all technical and operational assignments
Master’s Degree in Engineering with 3+ years of experience in software development and drilling automation related to drilling fluid properties management and drilling hydraulics
1+ years of mud engineering experience
Knowledge of water- and oil-based drilling, drill-in fluids and completion fluids as well as heat transfer and fluid mechanics in advance level
Computer programming skills and experience with MATLAB, C, C++, R, Python and CFD simulation software experience
Advance data analytical and numerical modeling skills
Experience in statistics methods and computational intelligence techniques
Knowledge of API testing procedures for drilling and completion fluids
Ability to resolve complex problems with broad scope
Ability to communicate well individually and in team environment
Should possess good understanding of FES equipment
Ideally 5+ years of experience in software development and drilling automation related to drilling fluid and drilling hydraulics
2+ years of field experience in drilling and/or completion fluids applications with both field and laboratory experience
Familiarity with Baker Hughes Drilling and Completion Fluids Engineering Solutions
Experience in machine learning techniques and optimization algorithms

116

Senior Beverage Development Scientist Resume Examples & Samples

New Product Development: Develops new beverages including juices, drinks, cocktails, teas, new age beverages and sauces as well as line extensions
Manages development, research, formulation, and duplication of new products from conception to shelf
Performs lab analysis, sensory analysis, and conducts market product evaluation
Sets ingredient product specifications and prepares final product formulations for testing and approval
Writes and completes detailed accurate reports on analyses, experiments, projects and final product. Documents formula calculations, process and ingredient requirements
Maintains formula records in QAD. Attend new product start-ups in the plant locations
Coordinates directly with purchasing on sourcing new ingredients. Recommending new suppliers, getting required documentation from suppliers. Following up with suppliers on quality issues
Coordinates with regulatory and food safety team on desired claims, call outs, and any new ingredients
Trains other scientists on flavor development and gives constructive input and feedback at group tastings. Recommends next steps for improvement
Performs organizational / administrative tasks such as processing standards management, maintaining laboratory inventory, and processing guide changes
Analyzes sensory results and performs yearly sensory training for corporate and the plants
Handles customer innovation sessions with sales and marketing
Learns and masters product development process and technology
Reformulates current products
Evaluates and tests new ingredients

117

Laboratory Development Scientist Resume Examples & Samples

Bachelors degree in genetics, molecular biology, or a related field
Minimum two (2) years of experience in clinical or analytical chemistry
As per the College of American Pathologists (CAP) and the Centers for Medicare and Medicaid Services (CMS), for Lab Development Scientist performing moderate or high complex point of care testing, a copy of a diploma or transcript of the highest level of academic achievement to be on record with Human Resources upon hire
Familiarity with cancer genetics

118

Project Development Scientist Resume Examples & Samples

Develop in-depth knowledge of Leukemia Center research goals and areas of emphasis
Facilitate team interactions throughout the life of a project
Assist with identification of funding opportunities, grant writing and submission
Coordinate clinical trial design, writing and submission of clinical protocols
Assist with Investigational New Drug Applications (IND)
Organize manuscript writing, data presentation and journal submission
Work with investigators to assure the clarity and accuracy of data presentations, as well as the interpretation of results
Assist in training of junior faculty for grant, manuscript and protocol writing
Requires a PhD in biology, biochemistry, or other life science; or, a master’s degree with at least five years of scientific writing, clinical study design, or clinical trial regulatory experience in a healthcare/research/academic environment
Preferred Experience: NIH or DOD research grant writing (R01 level, not post-doctoral fellowships), involvement with human observational or therapeutic studies, protocol design/writing for human sample, observational/retrospective or therapeutic studies. Familiarity with data analysis techniques, graphing methods, and interpretation of laboratory and clinical data
Skills:Excellent scientific writing, organizational and interpersonal skills are key
Aptitude:Ability to work independently and as part of a team, meet deadlines, perform and prioritize multiple simultaneous tasks. Requires judgment that could affect the image of City of Hope and the Leukemia Center
Software:Proficiency in use of Microsoft Word, EndNote, Excel and Powerpoint. Prefer familiarity with Adobe Acrobat and Illustrator
Communication:Strong written and verbal English is required

119

Research & Development Scientist Resume Examples & Samples

With limited supervision, design and execute experiments for development and evaluation of physical and/or chemical performance of new products or processes
Knowledge and application of fundamental chemical/engineering principles to solve product development problems
Break down complex problems into feasible/manageable solutions
Use scientific and statistical methods & techniques to analyze and interpret experimental data and make data-based technical decisions
Assess results for applicability, validity and conformance to specifications
Analyze data and prepare technical reports for management
Effectively work and communicate with all levels of the organization and promote and contribute to a cohesive team working culture
Participate in cross functional teams in technology and product development
Conduct general lab maintenance
Comply with HSE procedures with all technical and operational assignments
Participate in customer and vendor interface, with or without team leader
Execute assignments according to stated objectives and timeline
Bachelor's Degree in Chemistry with 10+ years OR Master’s Degree in Chemistry with 5+ years of laboratory, chemistry, or drilling and completion fluids experience
Advanced knowledge of Organic Chemistry
Advanced experience in Analytical Chemistry and techniques
Experience with ISO 9001 quality system
PhD in Chemistry is preferred
Drilling and Completion Fluids or Chemicals knowledge
Experience in drilling fluids and/or completion fluids applications in a laboratory or field setting
Familiarity with Baker Hughes Drilling and Completion Fluids products

120

Technical Service & Development Scientist Resume Examples & Samples

Uses broad market, customer and application knowledge and understanding of the competitive technologies to solve complex technical issues
Convinces others about differentiated technical solutions. Articulates synergies between technologies to maximize value effectively and understands how business value is created for Dow and the customer
Coaches others in identifying opportunities and how to understand and articulate value of Dow technologies in different applications
Communicates and appropriately documents work in the form of internal reports/ROC's/presentations, technology manuals, knowledge management resources, external reports, and patents when appropriate
Serves as principal author on papers and presentations and presents at industry conferences
Drives the definition of the TS&D requirements for a region and anticipates TS&D needs and implements steps to use TS&D as a way to differentiate Dow from the competition
Manages tech service for Tier II customer accounts
Serves as the EH&S advocate for work group, ensuring understanding and adherence to policies and procedures. Leads team in promotion of best safety practices, habits, and behaviors
A minimum of a Bachelor's degree in Chemistry, Engineering, Materials Science, or Physics is required
Ability to travel up to 30% of the time as needed
Strong technical, organizational and troubleshooting skills are required (interpersonal skills)
A Ph.D. is preferred
At least 3 years of relevant experience is preferred
Excellent written and oral communication skills needed
Six Sigma experience is desirable
Ability to multi-task and manage competing priorities
High bias for action and independent decision making
Ability to interact across functions, levels and businesses
Strong technical background in polymer application / transformation technology is a plus
Scientific methodology knowledge, polymer science, physical properties and analysis, polymer processing and rheology and knowledge of thermoset materials, chemistry, processing, applications and performance measurements
The job will also require a person able to deal with diversity and conflicts which are inherent to the broad scope of the job

121

Analytical Development Scientist Method Development Resume Examples & Samples

Extensive theoretical and hands on experience of analytical chromatography techniques: including HPLC, UPLC (reversed phase, size exclusion, IEX)
Proven track record of analytical method development and method qualification/validation gained within a similar environment
Educated to BSc/MSc/PhD in a relevant scientific discipline
Experience of other lot release and stability methodologies, for example capillary gel electrophoresis techniques (including SDS-PAGE, IEF)
PhD in a related area

122

Development Scientist AST Resume Examples & Samples

A degree or equivalent in chemistry, pharmaceutical sciences or a related topic. Experience of analytical techniques, especially HPLC
A degree, or equivalent, in a microbiological (or related) subject. Experience in a microbiology laboratory with the ability to demonstrate competency in microbiological techniques
Transfer to production experience
Experience as an end user of antimicrobial susceptibility testing products
Experience with MS Project

123

Research & Development Scientist Resume Examples & Samples

Development of high-performance LC/MS instrumentation and related technologies in a highly motivated multi-national multi-disciplinary team in Bremen, Germany
Execution of feasibility studies to show the proof of principle of new development ideas
Leading design and test of new mass spectrometer platforms
Development of system requirements specifications for a new product in cooperation with product marketing
Technical guidance of scientists, mechanical engineers and electrical engineers
Practical and theoretical characterization of newly developed instrumentation
University (preferably PhD) degree in physics, engineering, chemistry or related science
Proven 3-5 year experience in development of complex instrumentation, preferably in the field of mass spectrometry
Preferably, experience in writing programs for instrument control applications using Python, C, C++, Visual Basic, or scripting languages
Excellent written and oral communication skills in English, willingness to learn German
Very good teamwork skills

124

Application Development Scientist Automation & Liquid Handling Resume Examples & Samples

Develop user friendly, pre-programmed applications for the execution of complex sample preparation protocols that can be run by laboratory personnel with little/no experience running or programming liquid handlers
Program software add-ons that expand the capabilities of liquid handling workstations beyond the features and commands that are available in the released software and/or allow the integration of new tools with the liquid handling workstation
Work with engineers and software developers to define requirements for instrument capabilities in order to support new types of applications
Support new product development by designing and executing test protocols to ensure that new instruments meet user requirements and perform to specifications
10-20% travel to support FAS teams and customers with training and troubleshooting
Assist in the writing of application notes and white papers related to automation/ workflow method development and testing
Bachelor’s or Master’s degree in Computer Science, Computer Engineering, Biomedical Engineering, or related field
Minimum 1-2 years industry experience working with instrument development
Proficiency with various programming languages including but not limited to: C, C++, and Visual Basic
Competency with AutoCAD, MATLAB, Microsoft Office software
Laboratory experience with molecular biology, biochemistry, cell biology, or related field with ability to independently follow experimental protocols and interpret/present results in a clear and concise manner

125

Biological Development Scientist Resume Examples & Samples

Quantitate antigens using antibody-based assays including ELISA and Western blot
Generate recombinant DNA constructs using techniques including nucleic acid extraction, PCR, gel electrophoresis, plasmid DNA cloning, and bacterial transformation
Maintain cell cultures and perform transfection for transient protein expression
Perform virus and bacteria isolation, titration, and characterization
Support generation of analytical assays and reagents such as antibodies and proteins
Work with laboratory animal samples for pathogen isolation and immune response detection (e.g. serum antibody titrations)
Keep accurate experiment records
General background in microbiology
Basic knowledge of antibody-based immunoassays (e.g. ELISA and Western blot)
Experience in molecular and cellular techniques
Hands-on experience with viruses and bacteria
Ability to work as part of a team, self-motivation, adaptability, fast-paced, timeline driven and a positive attitude
Bachelor's degree in biology, microbiology, biochemistry, molecular biology or other related disciplines with 1-2 years working experience in biological research laboratory

126

Research & Development Scientist Resume Examples & Samples

Independently designs and optimizes experiments and assays
Analyzes data in depth and creates reports to show case the results
Continuously maintains accurate records, electronic and physical
Collaborates with team towards lab objectives, and with other teams to contribute novel ideas

127

Development Scientist Resume Examples & Samples

Developing oral solid dosage forms utilizing particle coating and fluid bed-technologies
Doctorate’s degree and 1+ years related experience in the pharmaceutical or biotech industries preferred
Master’s degree and 6+ years related experience in the pharmaceutical or biotech industries
Bachelor’s degree and 10+ years related experience in the pharmaceutical or biotech industries; or equivalent education, experience and training
Preferred degree in Pharmaceutical Sciences, Formulation Sciences, Chemical Engineering or Pharmacy
Experience in developing oral solid dosage forms with an expertise in particle coating and fluid bed-technologies is preferred
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you

128

ADC Development Scientist Flow Cytometry Resume Examples & Samples

Extensive hands on, technical experience with flow cytometry in a development environment
Experience of mammalian cell culture ideally work with mammalian tumour cell lines
Experienced with protein characterisation techniques
Extensive biology research laboratory experience in a Biotech/pharma environment
IT fluency in Microsoft office, Graph-Pad Prism as well as use of Intellicyte/FlowJo cytometry software
1st or 2nd BSc or PhD in a relevant scientific subject
Experience working in a biologics/antibody environment
Possessing a Bio-Safety Practitioner Level 1 certification
Experience with and use of Shimadzu UPLC chromatography software and hardware
Use of Biacore and GE Healthcare AKTA software
Experience of using imaging microscopy

129

Development Scientist Cell Culture Platforms Resume Examples & Samples

Standardize and improve Bayer’s bioprocesses by maintaining and keeping up-to-date on relevant technical knowledge in the area of mammalian cell culture processes by either reading relevant technical literature and/or by participating in related external conferences
Define the scientific and engineering principles needed for understanding and overcoming process development issues
Recommend new and innovative solutions to problems, while considering GMP requirements when proposing and implementing new reagents or methods
Independently design and conduct process development experiments of considerable complexity with considerable discretion as to work details requiring complicated scientific analysis, operational planning and execution
Analyze and interpret simple to complex data sets; troubleshoot failed experiments; define cellular physiology, and make improvements as appropriate
Ensure that laboratory notebooks are consistently updated, audited and well-maintained
Effectively communicate complex scientific and development findings in one-on-one discussions, and department and functional meetings
Provide first-authored, high quality internal reports, external papers and proceedings, and contributions to patent applications regarding technical achievements
Degree in Chemical Engineering, Biochemical Engineering, or related biotechnology fields
Minimum years of Industrial experience in pharmaceuticals or biotechnology; or related fields is 0 years for Ph.D., 6 years for M.S., and 8 years for B.S
Excellent learning ability with passionate desire to apply the learning towards the science and engineering of mammalian cell culture processes
Proficiency in process design and analysis, as it pertains to bioreactors and cell culture processes (Material Balances, Transport Phenomenon, Reaction Kinetics, and Process Control)
Ability to perform laboratory procedures as well as operate bioreactor systems, following SOPs with high attention to detail
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining results
Ability to solve complex and diverse scientific problems requiring original thinking and deductive reasoning
Good working knowledge of Microsoft Word and PowerPoint; excellent working knowledge of Excel
Mathematical skills (algebra, differential equations, and statistics) needed to reduce raw data to measured rates, quantify cellular physiology, compare processes, and perform numerical simulations of processes
Familiarity with a computer programming language, in order to be able to implement programs within proprietary bioreactor system software platforms
Excellent verbal and written communication skills, including writing of scientific and technical reports and presentations

130

Development Scientist Resume Examples & Samples

Develop the commercial manufacturing process to increase robustness and operational output
Document and coordinate the investigation of product performance issues
Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results
Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support process transfers and regulatory filing
Liaise with Material Sciences R&D team to support investigations, raw materials monitoring and continuous learning process
Liaise with vendors to validate & monitor their micronisation process, and develop an understanding of material aspects, and their interactions with the commercial manufacturing process
Prepare technical aspects of the regulatory submission for initial filing and for post approval changes and variations in the US and Europe

131

Scientifique des Methodes de Developpement en Chimie Analytique Method Development Scientist Resume Examples & Samples

Ability to develop novel analytical methods for a wide range of analytes, mainly small and large molecule pharmaceuticals to GLP regulatory standards, and to oversee validation of said methods
Experience in troubleshooting analytical methods and instruments
Advise clients on analytical technology and regulatory issues, and coordinate with clients throughout the method development cycle
Experience with Agilent 1100, 1200, 1260 and 1290 HPLC systems as well as Shimadzu Nexera’s, with Waters Corporation Empower 3 chromatography data capture software, essential
Also required is experience with Agilent Technologies 8453 UV/visible spectroscopy (with Chemstation software), and familiarity with LC-MS instrumentation
Possesses a PhD, M.Sc., or B.Sc. in chemistry or related discipline or suitable other experience
Minimum 10 years of experience working in a GXP-regulated environment and /or a Contract Research Organization (CRO), preferably with experience developing novel HPLC/UPLC methods pertaining to dose formulations
Is organized, responsible and dynamic
Self-motivated
Possesses excellent communication, interpersonal and teamwork abilities

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