Scientist, Development Resume Samples

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C Weber

Cydney

Weber

852 Hane Crossroad

Phoenix

+1 (555) 486 3941

852 Hane Crossroad

Phoenix

Phone

p +1 (555) 486 3941

Experience Experience

Chicago, IL

Scientist Product Development

Chicago, IL

Schuppe Group

Chicago, IL

Scientist Product Development

Design and execute of lab experiments, benchmarking, and test method development linked to performance in manufacturing
Follow product development process and project management discipline - development and execution of target products
Writes internal/external technical reports and contributes occasionally through patents, publications or presentations, documenting company technical achievements
Follows charters and goals for research, service in the field, training, product QA/QC and product development in the laboratory
Attend trade shows and conferences to keep abreast of industry and technical developments
Develops new technologies in the area of drilling fluid’s systems and additives
Performs research and experimentation with the minimal direction of technical leaders. Demonstrates creativity in solving scientific problems

Boston, MA

Scientist, Translational Development

Boston, MA

Nader, Bartoletti and Carter

Boston, MA

Scientist, Translational Development

Developing and optimizing clinical-grade assays to analyze drug effect in clinical samples
Providing scientific leadership and correlative biology support for marketed agents
Prepare and present work at group meetings
Interact with manager and project team to review data and plan next steps
Design and execute experiments independently and with high efficiency and accuracy
Understand and execute on role tasks
Actively participate in the development of cell-based assays for mechanistic studies, including biomarker discovery

present

San Francisco, CA

Senior Scientist Translational Development

San Francisco, CA

Kirlin-Nolan

present

San Francisco, CA

Senior Scientist Translational Development

present

May manage one or more employees and takes part in their annual goal writing and performance appraisal ensuring that employee development objectives are met
Analyzes data, draws conclusions, writes technical reports, makes suggestions based on results of experiments
May act as a supervisor/manager to lower level personnel
May be involved with HR to help manage conflict
Develops cell manufacturing procedures
Effectively contributes to complex work group or long term project with the objectives of a department, function and overall company
Works closely within a matrix environment and communicates with other members of multidisciplinary teams

Education Education

Bachelor’s Degree in Cell Biology

University of North Texas

Bachelor’s Degree in Cell Biology

Skills Skills

Advanced knowledge of human cellular or molecular biology and experimental techniques as it pertains to cancer and other human diseases
Ability to effectively navigate on-line biological databases including NCBI (e.g. PubMed, Entrez, etc.), EMBL, Sanger, etc
Good coaching and mentoring skills
Excellent time management skills as well as the ability to prioritize and level set expectations surrounding development projects and timelines
Outstanding problem solving and analytical skills
Effective organizational and interpersonal skills
Effective communication skills and strong presentation skills
Ability to write scientific and technical documents for internal and external communications relying heavily on attention to detail including, but not limited to, proposal development, price models, assay descriptions, etc
Ability to effectively execute multiple tasks or projects
Ability to establish and maintain effective working relationships with co-workers, managers, and clients

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15 Scientist, Development resume templates

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Pv Scientist Development Lead Resume Examples & Samples

Solid understanding of the clinical development and regulatory reporting process
Ability to conduct safety data reviews for investigational and/or post marketed products
Experience in the preparation of development aggregate safety reports and responses to ad hoc regulatory queries
Ability to work independently, take initiative and complete tasks to deadlines

PV Scientist Development Head Resume Examples & Samples

Minimum of 10 years previous experience working in a global pharmaceutical Pharmacovigilance Department, with experience in managing a group of Pharmacovigilance personnel
Supervisory experience at middle management level required
Extensive experience in the support of clinical development and reporting to Regulatory Authorities worldwide
Strong understanding of the clinical development and regulatory process
Experience with utilizing a global safety database, assessing cases for reportability, and performing QC
Competence in conducting safety data reviews for investigational and post marketed products
High level of expertise and experience in the preparation of aggregate safety reports including PBRERs, DSURs, CTLLs, IND Annual reports and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of these safety reports
Ability to contribute to and review standard operating procedures and other process-related documents
Excellent communication, collaboration, influencing and networking skills
Strong understanding of the interface between Pharmacovigilance and external departments
Forward-planning and proactive

Pv Scientist Development Lead Manager Resume Examples & Samples

30%
Strong understanding of the clinical development and regulatory reporting process
Practical experience in the interpretation of global Pharmacovigilance regulations and implementation within an industry setting
Strong ability conducting safety data reviews for investigational and/or post marketed products
High level of expertise and experience in the preparation of development aggregate safety reports and responses to ad hoc regulatory queries; significant experience in the mentoring, training and assessment of staff involved in the preparation of development aggregate safety reports
Experience with MedDRA and drug coding reviews
Excellent communication, collaboration and networking skills
Ability to influence others within a matrix environment
Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands

Pv Scientist Development Lead Resume Examples & Samples

30%: Product Management/Oversight
20%: Safety Review Team Coordination and Signal Detection
20%: Support for Investigational Products and Registration Activities
10%: Alliance Management for Outsourced PV Work

Research & Development Data Scientist Resume Examples & Samples

Work with other developers and data scientists to code proof-of-concept projects on large scale data sets
Develop data processing and system integration applications
Construct web based user interfaces and visualizations
Document design decisions, code and work flows
Migrate successful proof-of-concept projects into production environments
Quickly ingest new technologies to consider applicability to current or future needs
Utilize statistics and predictive analytics to create innovative solutions to business problems
Perform special projects as requested
Requires a Bachelor's degree in Math, Statistics, Computer Science or a related field
A combination of education and experience may meet requirements
Requires advanced analytical, organizational and problem solving skills
Ability to elicit, gather and analyze user requirements
Ability to work independently and provide updates to management
Requires strong interpersonal skills
Must be able to meet deadlines
6 plus years of experience in various programming languages, including R, TCL, JAVA, Ruby, and/or Python
Understanding of SQL and NoSQL data stores and solutions required
Knowledge of search technology such as Solr, Lucene, and other

Pv Scientist Development Lead Resume Examples & Samples

30%: Product Management/Oversight May act as a functional line manager to PV Scientists or a manager for a product or group of products. Oversight and assumes responsibility for assigned therapeutic products and PV activities. Supports an organizational structure that meets the evolving needs of Shire and the PVRM department. May be responsible to manage the development, objective setting and performance assessment of direct reports. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the PV Scientist Team Lead, Therapeutic Area Head, Head of Shire Pharmacovigilance and Risk Management and the Qualified Persons for Pharmacovigilance, including the EU QPPV
20%: Development Aggregate Report Production. Responsible for the production of aggregate and ad-hoc safety reporting for therapeutic team products, where Shire is the Global Safety Database holder. Establishes project management responsibility for development aggregate reports (e.g. DSUR, topic reports) within the therapeutic team to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report and regulatory timelines are met. Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and utilizes Shire’s EDMS system to provide quality control
20%: Safety Review Team Coordination and Signal Detection. Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned Shire products. Responsible for efficiently planning routine and ad-hoc Safety Review Team (SRT) meetings and ensuring that stakeholders provide input from their respective areas of responsibility. Ensures that regulatory commitments and risks described in the product Risk Tracking Document are efficiently tracked and presented as part of the SRT process. Works with SRT Co-chairs to facilitate communication and support for decisions resulting from the SRT. (e.g. update of RMPs, labeling, regulatory notifications)
20%: Support for Investigational Products and Registration Activities Effectively collaborate with stakeholders outside of PVRM. Represent PVRM department in cross-functional clinical programs and registration activities and provide PVRM support for clinical developmental programs
10%: Alliance Management for Outsourced PV Work. Provide guidance and oversight for CROs performing activities related to clinical trial SAEs

Scientist, Monster Product Development Resume Examples & Samples

Ingredients: Knowledge of and experience with key ingredients used in production of concentrates and beverage bases (e.g., caramel, citric acid, sodium benzoate, phosphoric acid, natural flavors)
Beverage Manufacturing: Knowledge of and ability to apply carbonated and non-carbonated beverage processing techniques (e.g., proportioning, carbonating, syrup manufacturing, filling)
Computer Skills: Knowledge of Microsoft suite of programs (Word, Excel, PowerPoint, Outlook), formula/database type systems, and capable user
Internet: Knowledge of Internet search techniques used to find required information (e.g., technical facts) and monitor sites of interest to the department
Laboratory Practices: Knowledge and application of Good Laboratory Practices (e.g., handling of chemicals and glassware, preparation of standards and reagents, proper measuring techniques, data management, housekeeping)

Scientist, Monster Product Development Resume Examples & Samples

Ability to understand product, package and equipment interactions
Perform chemical analyses using instrumental methods in order to
Basic Microbiology: Basic knowledge of food and water microbiology used to make judgments about the safety of ingredients, beverages, manufacturing techniques, packaging and storage conditions
Basic Physical Chemistry: General understanding of all aspects of physical chemistry that are relevant to Company products
Basic Project Management: Knowledge of project management principles and the ability to apply the principles, tools and techniques to develop/plan, manage or execute projects or work plans to ensure successful completion (e.g., on time, within budget)

Pv Scientist Development Lead Resume Examples & Samples

30%: Leadership of Therapeutic Team
20%: Oversight of Development Aggregate Report Authoring. Establishes project management responsibility for development aggregate reports (e.g. DSUR, topic reports) within the therapeutic team and oversees Pharmacovigilance Scientists/Managers to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report meeting regulatory timelines. Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Is accountable for the quality of the final document and utilizes Shire’s EDMS system to provide quality control approval
20%: Support for Investigational Products and Registration Activities. Effectively collaborate with stakeholders outside of PVRM. Represent PVRM department in cross-functional clinical programs and registration activities and provide support to PV Scientist Leads for clinical developmental programs
Minimum of 8 years previous experience working in a global pharmaceutical Pharmacovigilance Department, with experience in managing a group of Pharmacovigilance personnel

Scientist, Open Development Resume Examples & Samples

Comprehensively monitor vendor to ensure the prompt availability of quality products for business that are safe and effective, and in line with brand/category strategy
Manage vendor’s daily research and work, provide professional suggestion in formula if needed
Effectively communicate with vendor to ensure launch commitments are met with regard to lead times and costs
Corporate with purchasing team to validate the vendor’s qualification

Scientist, Bioassay Methods Development Resume Examples & Samples

Writing analytical sections of regulatory submissions is expected as the successful candidate will support regulatory filings including INDs and BLAs
Bachelor's degree in Biology, Chemistry, Pharmacology, Microbiology or other relevant scientific field, with at least 6 years of industry experience OR a Master's degree with at least 3 years of industry experience OR a PhD with relevant academic or industry experience is required
Experience with the development of cell-based bioassays and/or immunoassays is required
Experience with vaccines, antibody based therapeutics, or novel biologic therapeutics such as peptides, and microbiome therapeutics is preferredR&D

Research & Development Microbiologist Scientist Resume Examples & Samples

To partner with R&D formulators and across broader technical community to guide formulation microbial hostility and quality design
Lead microbial testing, data interpretation and microbial risk assessments (MRA)
Lead MRA and microbial qualification for new raw materials and technologies
Lead innovation of new microbiology based technologies and capabilities
Lead advancement of microbial methods, models and work processes

Scientist, Biochem / Cell / Media Development Resume Examples & Samples

The individual will work directly with the members of the Cell Biology R&D team to support new and on-going projects within the Thermo Fisher product commercialization process
The successful candidate will possess an innovative mindset focused around cell culture media development for protein expression and advanced cell culture applications
The candidate will be the primary user responsible for operating and executing cell culture media optimization experiments using the Ambr micro-bioreactor system
Strong organizational and documentation skills will be necessary to support the culture media development needs arising from multiple projects
Media formulation experience, including batch record development and execution, as well as formulation scale-up, break-point analysis, guard-banding and shelf-life stability are required
Experience performing cell culture on small- and large-scale cultures is also required
Perform literature searches related to products under development. Interact with scientists in other business units to troubleshoot problems
The successful candidate will comply with all company safety regulations and procedures
Experience using automated platforms for high throughput cell culture media optimization
Demonstrated expertise in the design, development, formulation and scale-up tech transfer of serum-free culture media for mammalian and/or insect growth and protein expression
Demonstrated use of Design of Experiment for formula definition and optimization
Knowledge of mammalian and/or insect cell culture techniques
Demonstrated track record of completing tasks within established time lines
Demonstrated ability to generate new ideas, achieve results and solve problems

Scientist, Assay Development Resume Examples & Samples

Confirm and characterize hits from high-throughput screens by SPR
Apply SPR to further understand target biology and mechanism of action of compounds from early hit identification phase to candidate drug selection and beyond
Proficiency in Assay Development
Experience in protein biochemistry
Meticulous regarding documentation and data management
Experience with robotics and automation
Willingness to adopt new laboratory skills as needed
Proactive, responsible and positive attitude
MS or BS in Biochemistry, Biophysics or related field with 2+years (MS) or 5+years (BS) of academic and/or pharmaceutical industry experience in assay development
Experience using SPR, BLI, ITC, NMR and/or other biophysical methods for measuring protein-small molecule interactions
Experience with chemical modification of proteins
Sound knowledge in structural biology and enzymology
Experience working productively in a multidisciplinary team environment
Skills in managing multiple projects from different therapeutic areas with clear understanding of project needs and ensuring delivery of high quality data with communication of timeline

Scientist, T-cell Development Resume Examples & Samples

Develop, optimize and establish an in house engineered T cell production process using viral and non viral vector platforms
Optimize T cell isolation, enrichment, activation, transduction, expansion and cryopreservation
Optimize media and culture conditions, phenotype engineered T cells
Evaluate new technologies for engineered T cell manufacturing
Develop analytical methods to improve process efficiency
Analyze and present scientific results; document study results for enabling clinical studies
Organize and prioritize work to meet timelines
Work with a cross-functional product sciences team to advance the development of autologous T cell therapy products

Scientist, Downstream Bioprocess Development Resume Examples & Samples

Provides technical support and guidance for the design, development, scale-up, optimization, monitoring, and/or operation of robust, cost effective, and scalable processes for the production of new or existing products
Development of robust downstream processes that can be scaled to large chromatography unit operations
Leading the examination of novel downstream technologies for manufacturing therapeutic proteins
Providing comprehensive packages that support equipment design and process technology transfer to manufacturing sites
Maintaining awareness of new developments, technologies and regulatory guidelines via scientific literature and external technical forums
Demonstrates solid understanding and use of engineering principles and practices to solve a range of complex problems in creative and practical ways
Leads technology transfer efforts of small project team between groups/organizations
Reviews manufacturing processes and/or development and production data; designs and conducts necessary experiments; contributes to understanding and interpretation of results; recommends changes or additional experiments. Leads a small project team
Provides technical guidance and trains less experienced staff
Bachelor’s degree and 8 years of experience or Master’s degree and 6 years of experience
Industrial experience in development of downstream process for manufacturing of recombinant proteins and antibodies
Exceptional interpersonal skills and ability to work effectively in a matrix organization

Scientist, Gene Therapy Development Resume Examples & Samples

Design and execute upstream process development activities for manufacture of gene therapy vectors. Manufacturing platforms may include stable mammalian packaging cell lines, Baculovirus production systems, or transient transfection
Lead process scale-up and process definition activities, to include the execution of small-scale and at-scale bioreactor campaigns
Participate in cell line generation, cell banking and stability assessment
Evaluate emerging technologies for implementation into process development and vector manufacturing, e.g. high throughput systems bioreactor modeling, process analytical technology, etc
Apply state of the art cell culture monitoring technologies; perform critical evaluation of cell culture performance data to identify trends and opportunities for improvement
Document and communicate scientific data to line management and functional sub-teams through lab notebook entries, technical and monthly reports, and oral presentations
Take ownership of and be accountable for development projects. Deliver on aggressive campaign schedules
Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available
Provide training and technical leadership to less experienced staff; incumbent may have managerial obligations for junior staff
Ph.D. and 0-2 years of experience
Experience in cell culture technologies, including bioreactor systems
Experience with cell banking technologies
Experience with aseptic cell culturing techniques in both flat stock adherent cultures (T-flasks/cell factories/roller bottles) and suspension systems (shake flasks, wave and stir tank bioreactors)
Experience with cell culture monitoring technologies including cell counting, metabolite and gas analysis and culture assessment
Able to schedule multiple activities to maximize efficiency and productivity, including weekend schedules
Prior experience with cell culture process technology transfer to manufacturing setting is desirable, as is experience in a manufacturing setting with an understanding of current Good Manufacturing Practices (cGMP)
Experience with Baculovirus-based protein or virus production systems
Experience with Quality by Design (QbD) and Design of Experiments (DOE) is a plus
Familiarity with viral vector manufacturing systems and a BSL2 environment is a plus
Must work effectively in a team. Must possess effective communication skills both written and oral. Will work to meet deadlines while adapting to changing priorities

Scientist, Bioanalytical Development Resume Examples & Samples

An advanced degree (PhD or PharmD) in a chemical, biological, pharmaceutical, or related field with at least 4 years of experience
Report writing to encompass findings during testing to be used by the toxicology and PK scientists
Experience with bioanalytical testing
Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting are required
Experience with traditional large molecule analysis platforms (ELISA, ECL), novel high-sensitivity platforms, and hybrid platforms
A working knowledge of GLPs, relevant guidance documents, and white papers
Experience with robotics
Proficient with LIMS software and data management
Experience with managing direct reports

Scientist Immune Monitoring & Biomarker Development Resume Examples & Samples

Lead project assay development and testing
Perform routine immune assays and assay optimization using human biological samples (serum, tissue, PBMC)
Perform data analysis
Provide guidance and supervision to RAs
Participate in cross-functional project teams

Scientist, Assay Development Resume Examples & Samples

Designing and evaluating point of care diagnostic assays and assay components. Scope includes lateral flow immunochromatographic and other assays such as ELISAs and various microfluidic applications and may also include NAAT assays and live pathogen assays
Managing as well as carrying out assay product development efforts such as design, experimental verification, data review, and tests to characterize system and subsystem performance, including evaluations using clinical samples in lab and field settings
May also lead facilitation, coordination and alignment with internal and external partners in co-development, or productization/design for manufacturing, and lead all or part of an assay development project
Must be willing and able to be hands-on in the laboratory, capable of designing and performing experiments as well as supervising others performing them
Substantial hands-on experience with clinical immunoassay R&D; experience with microfluidics, lateral flow assays and clinical diagnostic product development desired
Experience and recent practice in lab settings and willingness and ability to productively work in lab settings. Experience with experimental and evaluation data analysis, biostatistics, and presentation of results in various formats, including in high profile public and internal settings
Experience managing scientific staff and managing diagnostics R&D projects a plus
Highly proactive and self-directed in identifying personal as well as team-wide knowledge and/or skill gap, and adept at acquiring the technical background needed to fill those gaps
Minimum educational requirement is a PhD or equivalent in a life science or engineering discipline or closely related field, with 5+ years of industry or academic lab experience

Scientist Nonclinical Development Resume Examples & Samples

The candidate will work as an interface between early research and nonclinical development. He will coordinate cross-functional and scientific input to compile integrated preclinical asset reports and development plans
The candidate will support the integration of inlicenced products and will coordinate non-clinical regulatory toxicology activities with business partners and regulatory affairs
The candidate will assemble and provide responses to inquiries by authorities throughout the life cycle of a product
The candidate is supporting nonclinical programs as an nonclinical regulatory expert in cooperation with the nonclinical project experts
The candidate works in a team of medical writers, scientists and managers
The responsibilities are applicable for all Baxalta/Shire divisions including Hematology, Oncology, Immunology and Biosimilars
MSc or equivalent or higher degree in Life Sciences, veterinary science or comparable, medical or pharmaceutical background
Experience in pharmaceutical industry in the field covered by the Job profile of 2-5 years
Experience in nonclinical development, knowledge of the drug development process and relevant regulations (ICH and eCTD regulations) mandatory
ADME knowledge of advantage
Ability to distil, assess and report complex data
Excellent knowledge of written and spoken English
Flexible team player with well-developed communication and organizational skills
Ability to work accurately and compliantly to high quality standards during changing conditions and under tight timelines
Excellent knowledge of MS Office applications MS Word, Excel, PowerPoint and Adobe Acrobat, advanced scientific writing skills, including graphical/tabular presentation of data

Scientist DP Phys-chem Analytics Analytical Development & QC Resume Examples & Samples

Help establish DP analytical infrastructure and services for biologics, small molecule and peptide parenteral products for clinical and commercial products
Install, qualify and maintain instruments for DP phys-chem analytics in close alignment with current best practices and regulations
Develop and establish analytical methods and technologies to support formulation development and DP QC (specifically including HPLC and CE purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection, subvisible particles and related DP analytics)
Carry out phys-chem analytical tests to support formulation development and DP QC as required, possibly under GMP, following applicable SOP’s and all current documentation practices
Ensure proper maintenance of equipment, safety and health protection following lab and safety instructions and all cGMP regulations
Evaluate and implement new methods and technologies, as required; participate and contribute to innovation, technical strategy projects and scientific publications
> 4 years of experience as a research/ technical assistant in the pharmaceutical or chemical industry, preferably in analytics
Working experience in relevant analytical techniques
Experience with parenteral dosage forms, protein formulation and analytics is a plus

Research Scientist, Product Development Resume Examples & Samples

Conduct research under the direction of supervisor
Plan, conduct, analyze, and report experimental results
Understand physical principles involved in assays to perform intelligent troubleshooting
Maintain records of the experiments conducted
Prepare presentations for updating supervisor, other team members, and R&D as appropriate
Implement and improvise protocols of analytical instruments necessary for successful completion of project

Scientist, Assay Development Immunobiologics Resume Examples & Samples

Support drug discovery programs by providing relevant scientific and strategic input to project teams regarding invitro pharmacological studies
Design and execute screening assays that enable the selection and characterization of desirable therapeutic leads against disease targets for IO applications, including development and validation of novel, cellular immunological and biochemical assays
Contribute and implements new ideas and in vitro proof of concept studies to enable initiation of new discovery project concepts
Function effectively as a part of both functional and cross functional teams by interfacing with project teams to meet timelines and blueprints for target product profile
Works effectively as a member of multi-disciplinary, cross functional teams
Presents research findings clearly and effectively at internal and external meetings and with participants of all levels of the organization
May lead pipeline related projects in cross functional teams
Maintain familiarity with the current scientific literature in the Immunotherapy field, contribute to new target ideas and concepts
Maintains accurate, complete and timely data entry into laboratory notebooks
PhD in Immunology/Cell Biology with postdoctoral training and a minimum of 2+ years of relevant experience, preferably in industry
Extensive hands-on experience and knowledge in a wide range of biochemical and cell based assay development with biologics in immunology, inflammation or related areas is required
Hands –on experience and ability to work with minimum supervision in carrying out high throughput data acquisition, analysis, storage and reporting by FACS, ELISA, Luminex, and additional highthroughput assay formats is required
Experience with primary human and rodent immune cells is strongly desired
Use of scientific databases and application for data management and data analysis
Hands on experience with automated platforms

Research Scientist, Solution Development Resume Examples & Samples

Good knowledge of product development stages (development, stability, clinical, registration, process transfer, production, suppliers, customer service) and product development process (Tx-PDP / Design Control)
Knowledge of Renal (PD / HD/CRRT), Nutrition and/or IV therapies and products is a plus
Good knowledge in formulation / solutions development
Open for innovation and proposal of new ideas. Contribute to the exploration of new ideas. Have good creativity thinking skills
Good knowledge in statistical analysis
Working knowledge of international/regional/national regulations and standards (e.g. ICH, FDA, …)
Utilize a logical, methodical approach (such as DMAIC) independently solving problems, developing solutions, and making recommendation
Ability to interpret results from complex instrumentation and scientific studies
Good ability to lead cross-functional teams
Excellent technical protocol & report writing skills
Strong cross-cultural communication skills, ability to identify, resolve or escalate potential issues to relevant stakeholders
Must be able to challenge the status quo
MS or PhD degrees in Pharmaceutics, Pharmacy or related field
MS with at least 6 years, or PhD with at least 4 year of relevant experience
Leadership of technical teams and project management experience is required
Experience in formulation development is required
GMP experiences in parenteral pharmaceutical industry would be a great advantage

Scientist Assay Development Resume Examples & Samples

PhD degree in the Biological Sciences
Experience with IVD product development is desired
A sound foundation in experimental design and molecular biology is desired
A desire to be part of a fast-paced dynamic Development environment

Scientist, Downstream Bioprocess Development Resume Examples & Samples

Leading the development of robust downstream processes that can be scaled to large chromatography unit operations
Applying DOE, MVA, APC and other techniques to determine design spaces and operating spaces for downstream processes
Leading efforts with colleagues from across Sanofi sites to achieve standardization and harmonization of downstream development and manufacturing practices
Publishing in first class technical journals
Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biology or related field with 0–2 years of experience

Scientist, HTS Assay Development Resume Examples & Samples

A minimum of a PhD in biochemistry, cell biology, molecular pharmacology or related field is required
Experience with biochemical and/or cell-based assays is required
Experience with methods such as luminescence, fluorescence, absorbance and radiometric detection is preferred
One or more publications in a high-quality peer-reviewed journal(s) is required
Excellent written communication, verbal communication, and oral presentation skills are required
Experience with 3D cell culture is preferred
Experience with protein or gene expression profiling is preferred
Experience in cardiovascular, immunology, infectious diseases, neuroscience and/or oncology therapeutic areas preferred
This position is located in Spring House, PA and will require up to 10% travelR&D

Scientist, R&D Product Development Resume Examples & Samples

This is a Center Research-based technical leadership role providing direction for and execution of projects across one or more of our North American businesses (Grocery, Refrigerated, Bev & Snack Nuts, Foodservice/KFI and Canada Zone). The candidate will be identifying, scoping and/or driving technical projects to meet business initiatives focused on Cost Engineering. This candidate should have a proven record of executing work plans and driving for results. This includes basic understanding of the business need, designing and executing tests, analyzing data, drawing conclusions, documenting, communicating results, and commercializing products. Proven communication and teamwork skills are essential in this role, which operates in a cross-functional environment. The candidate must also have a strong technical background and be able to apply prior learning or scientific principles to new situations. This position requires an individual to manage multiple assignments/ tasks concurrently and demonstrate the ability complete work with minimal guidance. Exhibiting a collaborative mindset and applying innovative solutions are a must
Demonstrates the willingness/ability to learn new product categories and/or processing/packaging areas
Adapt and apply scientific principles to new situations/products and have a moderate degree of autonomy

Scientist Assay Development Resume Examples & Samples

Hands on experience with mammalian cell culture in a BSL-2 environment
Experience generating and characterizing stable, attachment dependent cell lines
Experience developing and carrying out cell based assays for antibody discovery
Experience conducting ELISA assays, western blotting and molecular biology techniques
Candidate must have strong written and verbal communication skills

Scientist, Genomic Assay Development Resume Examples & Samples

Provides scientific guidance, training and mentorship to lower lever and new staff, directly supervise other scientists and be responsible for conducting periodic reviews, end of year assessments, review of laboratory notebooks/documentation for GCP compliance, and other management duties as applicable
Demonstrate technical proficiency, scientific creativity and independent thought. Develop new and existing experimental techniques including the design and execution of validation protocols and reports, as necessary
Serve as a consultant to internal departments or external sponsors/clients. This includes technical support and consultative project design and scoping through teleconferences, face-to-face meetings, and other mechanisms
Execute scientific experiments and develop new methods with minimal supervision, including accountability for devising short and long-term project goals, creating and adhering to timelines and budgets, and developing trouble-shooting strategies to address setbacks
Responsible for proposal development and project scoping in support of internal and external projects, for maintaining projects within scope, and for addressing scope changes with the client and with business development
Maintain scientific awareness of developments in genomics based on current literature, application of new technologies, attendance at professional meetings, etc. Represent EA Genomics and Q Squared Solutions by judicious development of professional relationships
Contribute to scientific literature, documentation and conferences through the preparation of peer-reviewed manuscripts, including the writing and/or creation of abstracts, peer-reviewed journal articles, poster presentations, and content to support marketing materials
Advanced knowledge of human cellular or molecular biology and experimental techniques as it pertains to cancer and other human diseases
Excellent computer skills including proficiency with Microsoft Office applications, as well as experience in bio-statistical software as needed
Excellent communication skills including the ability to directly interact with both internal/external clients. Must have the ability to think creatively and communicate scientific methods and principles to a wide variety of audiences
Ability to effectively navigate on-line biological databases including NCBI (e.g. PubMed, Entrez, etc.), EMBL, Sanger, etc
Good coaching and mentoring skills
Excellent time management skills as well as the ability to prioritize and level set expectations surrounding development projects and timelines
Outstanding problem solving and analytical skills
Effective organizational and interpersonal skills
Effective communication skills and strong presentation skills
Ability to write scientific and technical documents for internal and external communications relying heavily on attention to detail including, but not limited to, proposal development, price models, assay descriptions, etc
Ability to effectively execute multiple tasks or projects
Ability to maintain a high degree of independence with moderate direction needed to complete assigned tasks and projects
PhD Degree or educational equivalent in cell biology, molecular biology, cancer biology, pharmacology or related field with 8 years relevant experience; or equivalent combination of education, training and experience

Scientist, Genomic Assay Development Resume Examples & Samples

Adhere to all corporate policies, procedures and employee handbook contents
Develop and optimize molecular genomic test procedures for new and existing technology platforms, and work with other functional groups to specify and develop supporting infrastructure for test procedures
Recommend an appropriate level of testing, verification and/or validation for new technology platforms and test procedures and develop corresponding plans and summary reports
Predict and summarize capacity, costs, personnel, equipment, reagents and time requirements for test procedures and/or technology platforms being developed or implemented, including ongoing calibration and maintenance where required
Prepare newly developed test procedures for transition to Esoteric Testing or Laboratory Operations, coordinate with stakeholders to finalize training recommendations and requirements, and train personnel on new test procedures as needed
Identify quality control metrics for the initial and ongoing evaluation of new test procedures and technology platforms, and provide a preliminary range of acceptability. Monitor and refine quality control metrics and provide feedback to Laboratory Operations
Function in a team environment, recognizing that priorities will shift according to business needs, which requires a flexible work schedule
Other duties, as assigned
Working knowledge of CAP, CLIA and HIPAA requirements
Demonstrated expertise in the design and development of molecular biology methods
Excellent planning and organizational skills, and close attention to detail are essential
Capable of managing multiple projects simultaneously
Proficient user of standard office productivity software, along with basic statistical analysis
PhD or Masters in Molecular Genetics or related field, or equivalent combination of education and experience
Minimum of six years molecular biology lab experience, exclusive of undergraduate training
Experience in a clinical laboratory operating under CAP/CLIA guidelines is preferred
Direct experience with next generation sequencing method development is preferred

Scientist, HTS Assay Development Resume Examples & Samples

Develop assays in cell-based and biochemical formats that are suitable for automated high-throughput screening in 384 or 1536-well formats
Perform high-throughput screens
Analyze and publish screening data including presentation at program team meetings
Develop innovative approaches to screening and hit triage using, for example, 3D cell culture, co-culture, high-content imaging, phosphoprotein profiling or gene expression profiling
Attend in-house seminars and external scientific meetings as appropriate
PhD and postdoctoral experience in cell biology, biochemistry, molecular pharmacology or related areas is required
Expertise with cell-based assay development is required
Expertise with methods such as luminescence, fluorescence, absorbance and radiometric detection in plate-based format is desired
Expertise with 3D cell culture and/or co-culture of multiple cell types including iPS-derived cells is desired
Expertise with protein or gene expression profiling is desired
Expertise in cardiovascular, immunology, infectious diseases, neuroscience or oncology therapeutic areas is desired
Experience working with and guiding external collaborators in industry or academia is desired
Experience with membrane receptor pharmacology and physiology, including ion channels, G-protein Coupled Receptors (GPCRs) and/or transporters is desired.R&D

Clinical Development Director & Head Scientist Resume Examples & Samples

Advanced degree preferred e.g. MS, PhD, PharmD…
Demonstrated success in ability to lead in a heavily matrixed environment and working across boundaries
Advanced understanding of drug development processes and key interfaces
Detailed knowledge of clinical development, including submission work, knowledge of Phase IV (preferable in Respiratory)
Important to have a vision and demonstrated examples of ability to share your vision
Understanding and knowledge of the global drug development environment and how delivery of global drug development contributes to GSK business results
Record of successful people development
Advanced ability to problem solve
Proven ability to influence and negotiate with key internal and external stakeholders
Ability to interact effectively and productively with senior, VP level, staff
Proven ability to manage staff responsible for large budgets
Ability to deliver key process improvement initiatives in the medical and scientific areas
Ability to work independently and take decisions with minimal supervision
Excellent interpersonal communication skills
Proven ability to attract, develop and lead a large team

Senior Scientist, Purification Development Resume Examples & Samples

Maintain documented cGMP training and be prepared to assist Manufacturing as needed
Maintain documented laboratory safety training required to safely perform laboratory operations and handle hazardous chemicals
Occasional work days longer than 8 hours will be required to complete purification runs
Will frequently be required to stand for periods of an hour or more, walk, sit, talk and hear, use hands and fingers to assemble equipment, and use arms and step ladders to reach shelving
Will occasionally be required to lift and move objects up to 25 pounds in weight
Close vision, color vision and peripheral vision are required

Research Scientist, Assay Development Resume Examples & Samples

Design, develop, verify, and validate new immunoassay products in urine
Become the expert across our parent company (Alere) for the technology used and how it is implemented immunoassay panels on the Triage platform
The scientist must be an team-oriented, open-minded individual who is capable of managing their own aggressive timelines with minimal supervision
PhD in a related scientific discipline with 1-3 years related experience or MS in a related scientific discipline with 5-7 years related experience or BS in a related scientific discipline with 7+ years of related experience
Demonstrated skills in carrying out innovative research with minimal guidance in an accurate, effective manner

Scientist, Assay Development Resume Examples & Samples

Candidate must have experience managing biological specimens and applying principles and concepts of sample processing which include: nucleic acid extraction, heat inactivation, aliquoting, blinding/de-identification, sample destruction, resolution of patient/sample demographics and use of inventory and tracking software to be managed via regulated and compliant practices
Candidate experience working in a regulated laboratory environment
Candidate must have experience with Molecular biology assays such as DNA gel electrophoresis, DNA and RNA isolation and Real-Time PCR

Scientist Assay Development Resume Examples & Samples

BS or MS Biomedical Engineering or related discipline
Masters degree with 2-3 years of relevant experience or Bachelors degree with 5 years of relevant experience
Assay process development, evaluation and documentation
Experience with diagnostic techniques, fluorescence assays, enzymatic assays, and a variety of membrane materials is strongly desired
Well-versed in safe laboratory practices

Senior Scientist Translational Development Resume Examples & Samples

Involved in developing and optimizing procedures required for new product scale-up, purification, characterization, process optimization
Develops cell manufacturing procedures
Contributes to setting up product specifications in collaboration with relevant groups in Technical Operations
Works on complex problems requiring evaluation of intangible variables
Exercises independent judgment in designing and conducting experiments, developing research methods and evaluation criteria
Requires no instruction on routine tasks and minimal guidelines on new directions from the next line manager and acts independently in choosing research approaches for new assignments
Demonstrates expert knowledge of cell biology principles and technical proficiency in research methods
Maintains substantial knowledge of state-of-the-art principles and theories via staying current with scientific literature and breakthroughs in the field
Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways
Conducts literature searches used for design of experimental strategies
Analyzes data, draws conclusions, writes technical reports, makes suggestions based on results of experiments
May contribute to writing scientific papers
May contribute to preparation of documentation required for regulatory filings
May contribute to writing SOPs
Maintains accurate records as notebook/batch record/electronic entries
Collaborates with other groups inside and outside of Technical Operations as needed
May participate in the development of patent applications
Serves as in-house consultant on scientific and technical issues in product/process development
Demonstrates technical proficiency, scientific creativity, efficient collaboration with others and independent thought
Consistently completes work effectively and efficiently
Communicates effectively with manager, group members and other team members
Carries out work in compliance with Astellas Health and Safety policies
Uses professional concepts and company's policies and procedures to solve a variety of problems
Ensures projects are of high quality, on time and within budget
May manage one or more employees and takes part in their annual goal writing and performance appraisal ensuring that employee development objectives are met
May be a Project Leader for internal or cross-functional projects
May provide guidance and oversee the activities of other lower-level personnel
Works closely within a matrix environment and communicates with other members of multidisciplinary teams
Creates a positive work environment promoting teamwork, mutual respect, encouraging change, innovation, and accountability at all levels
Effectively contributes to complex work group or long term project with the objectives of a department, function and overall company
May be involved with HR to help manage conflict
May be involved in technology transfer and training of others
May be involved in external collaborations
May act as a supervisor/manager to lower level personnel
Ph.D. or equivalent degree in cell/molecular or developmental biology with 5+ years' academic or industry experience (including at least 2 years of postdoctoral training), OR an M.S. degree/equivalent with 7+ years' of academic/industry experience (including at least 5 years of relevant post-degree experience),
Solid knowledge of cell biology principles
Solid working knowledge of research methods in cell and molecular biology including proficiency in cell culture
Solid experience with various cell types in culture
Working knowledge of routine and semi-routine laboratory procedures
Knowledge of applicable laboratory equipment including automation
Stays current with scientific literature in the field, performs literature searches and creatively uses for planning research strategies
Demonstrated ability to independently design research strategy and effectively implement experiments in a timely manner
Ability to analyze data, draw conclusions, make scientific recommendations and troubleshoot
Proficiency in writing technical and scientific reports based on data analysis, ability to contribute to writing scientific manuscripts and prepare presentations
Ability to work flexible hours and weekends/holidays
Efficiency at managing multiple projects and working under deadlines
Result-oriented, self-starter, team player

Senior Scientist, CHO Cell Line Development Resume Examples & Samples

Develop and characterize highly-productive stable CHO cell lines suitable for cGMP biotherapeutic manufacturing within project timelines
Conceive, investigate and execute scientific research and development to significantly improve platform processes and workflows, develop new methods, build technical expertise and intellectual property, and deepen scientific understanding
Mentor/supervise one or more scientists and evaluate their performance; be accountable for their effective performance
Work collaboratively and cross-functionally on multiple projects with colleagues in
Process Sciences, Manufacturing Sciences, Biologics/Discovery and others to meet team and company goals
Proactively seek out new information and opportunities to advance our technologies and pipeline. Critically evaluate relevant scientific, regulatory and business advances and integrate this knowledge
Contribute to the smooth and effective operation of the CHO cell line development labs
Effectively present scientific data and concepts to internal and external audiences. Author and review technical reports, protocols and other key documents
Ph.D. in biological sciences or related discipline with at least 3-5 years of relevant experience in the biopharmaceutical industry (or MS degree with at least 10-12 years relevant experience)
Thorough practical and theoretical understanding of CHO cell line development to enable cGMP biotherapeutics manufacturing and associated areas of expertise (e.g., cell and molecular biology, process development, recombinant protein production, protein characterization)
Excellent interpersonal and communication skills. Strong scientific curiosity with a passion for problem-solving and optimization. Self-motivated with excellent attention to detail and ability to multi-task. Strong organizational, planning and trouble-shooting skills
Expertise in flow cytometry and cell sorting (FACS), high-throughput cell culture and screening technologies, and/or liquid handling automation are highly desirable
Supervisory experience a strong plus

Scientist Within Late Stage USP Development Resume Examples & Samples

You are responsible for the management of complex bioprocess development projects with focus on innovative new biological medications
Regarding a robust biopharmaceutical manufacturing beyond the edge of current knowledge you push our technology platform
In interdisciplinary project teams you are the independent upstream project team member
As Scientist you take over the technical and organizational lead of cell culture project sub teams including capacity planning and training
Moreover, you pass on scientific input to support targeted bioprocess development to meet predefined quality targets
You support rational bioprocess optimization, scale-up and transfer of processes as well as late stage work packages, such as risk assessment and process characterization studies for NBEs and biosimilars
Furthermore, you take care of the project reporting and support in compiling documents required for fillings

Research Scientist, Packaging Development Resume Examples & Samples

Manage assigned packaging development projects
Support identification of packaging development strategy for assigned NPD projects
Support, develop and communicate timelines and cost for assigned projects
Coordinate and assist in the execution of laboratory development activities
Provide oversight of junior level packaging development colleagues to execute experimental plans and batch packaging / manufacturing
Coordinate external development activities, as required, by providing technical leadership and accountability for delivering timing commitments
Lead development of and / or author technical documentation to support launch and regulatory approval of projects (i.e. Development Plans, Development Reports and Technical Regulatory Documentation)
Act as technical expert for packaging technology by providing sound technical expertise to Innovation Team, Category Leads, Technical Sub-teams, and Category Technical Leads
Bachelor’s Degree with a minimum of six (6) years of package development experience; or
Master’s Degree with a minimum of four (4) years of package development experience; or
Ph.D with postdoctoral experience
Ability to balance innovation, cost and manufacturability of new package
Team player that builds strong relationships and can manage teams without direct authority
Experience generating packaging specifications and packaging batch records
Working knowledge of packaging unit operations and machinery at pilot and commercial scale
Ability to work independently and lead packaging projects

Senior Scientist, Culture Development Resume Examples & Samples

Executes experimental research plans in accordance with technical and business priorities and objectives
Identifies, assesses and develops new scientific concepts and/or technologies to provides solutions to identified problems
In conjunction with Group Managers and Senior Scientists, establishes the agenda, priorities and work plans; manages project teams in PCF – including planning project activities, tasks and end results, including work breakdown estimated, responsibilities, schedules and budgets. Approves project plans, as appropriate and gains approval for changes in scope, budget or time prior to execution of work
Provides proper feedback and recognition of teamwork and team accomplishments on a regular basis
Maintains a broad-based external knowledge of research and emerging technologies sourced globally, across relevant fields of study. Build and maintain scientific credibility and visibility in support of the business. Build and manage internal and external collaborations/partnerships in the discovery, R&D and commercialization of novel food protection technologies
Translates program strategies and project objectives into COTs. Manages portfolio of projects to deliver on time and on budget
Ensure appropriate level of interaction and direction with key internal stakeholders and partners, including business, SAFI, IDBs, T&BD, CR&D, Regulatory, Legal, Safety & Quality, Project Management Office, HR and other relevant groups
Manages projects and laboratories in accordance with all SHE policies and programs and quality assurance standards
Master’s Degree or PhD in Microbiology, Biology, Food Science, or related field, and a minimum of 10 years experience
Research experience with lactic acid bacteria and food fermentation, preferably in an industrial application
Knowledge and experience with molecular biology methodologies and bioinformatics
Demonstrated direct management of staff and demonstrated project management skills (min 6-years)
Ability to manage projects and programs, including complex, multidisciplinary approaches; ability to prioritize, manage and deliver against multiple assignments in a fast-paced, fluid environment, including managing the budget
Excellent technical writing skills and the ability to produce clear, accurate reports and presentations to the Technology and business stakeholders
Excellent interpersonal communication skills, both written and verbal. Ability to motivate and guide the efforts of others to successful project completion as well as successfully manage communication internally and externally

Scientist, Sterile Product Development Resume Examples & Samples

Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of parenteral, ophthalmic, and other sterile dosage forms
Participate in media fills for aseptic fill projects
Assist in the equipment set up, operation, maintenance, cleaning as required for the project
Perform environmental monitoring of manufacturing areas per applicable SOPs and maintain records
Assist with manufacturing area maintenance such as area monitoring and qualification, purchase of gowning supplies, purchase of equipment and room cleaning supplies, microbiological monitoring supplies
Maintain records for personnel gowning qualification
Execute product development studies under the guidance of supervisor or lead project scientist to support formulation development, and clinical drug product manufacturing
Assist lead formulators in activities such as but not limited to, material procurement, data recording and compilation

Senior Scientist Biopharmaceutical Analytical Development Resume Examples & Samples

Represent Analytical Sciences on project teams, collaborating closely with scientists from Process Development, Biologicals Research, Clinical, Regulatory, Project Management, and Manufacturing to deliver robust methods and products
Design and conduct laboratory experiments including analytical method development, validation and transfer. Primary techniques are HPLC, capillary electrophoresis, spectroscopic, thermal, and microplate assays
Develop and/or adopt new analytical technology, as appropriate, to advance programs with significant analytical technical and timeline challenges
Understanding of protein engineering and protein biophysical properties that relate to molecule stability and posttranslational modifications
Experience with biopharmaceutical development and licensure

Scientist Upstream Development Resume Examples & Samples

Planning, execution, documentation and reporting of upstream development studies such as fermentation in Batch-, Fed-Batch-, Chemostat- or Perfusion-Mode and harvest procedures
Use of advanced statistics software (Minitab, MODDE, SIMCA)
Proactive development and implementation of new technologies in Upstream processes (e.g PAT)
Supporting Tech Transfer and scale-up activities for drug product manufacture
Lead projects and cross-functional teams
Authoring / Reviewing scientific papers and presentation of results in international meetings
Proactive at keeping current standards with scientific literature and latest technologies
PhD in Biochemical Engineering, Biotechnology or similar (e.g. BOKU or TU)
Experienced in cell culture, fermentation and/or filtration preferred
Willingness to work in wet lab (10-30%)
Excellent communication, interpersonal and organizational skills
Ability to prioritize work and multitask
Expected to work independently with modest supervision, develop solutions to diverse problems, and demonstrate motivation in pursuing scientific answers through sophisticated planning that occasionally require cross-functional collaboration
Willingness to growth and share acquired knowledge with the team members
Excellent MS Office skills
Excellent English skills

Scientist Biopharmaceutical Analytical Development Resume Examples & Samples

Design and conduct laboratory experiments including analytical method development, validation and transfer. Primary techniques are HPLC, capillary electrophoresis, spectrophotometric, and microplate assays
Perform analytical methods necessary for the characterization and analysis of process and formulation samples
Collaborate with other scientists in a variety of technical disciplines including within Analytical Sciences, Process Development, Biological Research, Clinical, Regulatory, Project Management, Quality Control and Manufacturing
BS/MS in Analytical Chemistry, Biochemistry, or a related discipline with at least 3-4 years of related experience
Experience developing, validating and transferring biopharmaceutical analytical methods

Scientist USP Development Resume Examples & Samples

Development and characterization of cell banking and up-stream processes at bench and pilot scale for bacterial based vaccine production
Planning and execution of process development, investigation and troubleshooting activities related to particular projects in a cGMP and/or GLP environment
Achieve cost efficient USP manufacturing processes through optimization, characterization, scale-up and validation work and provision of the required documentation
Creation of study plans, study reports and master batch records with minimal supervision
Data evaluation using statistical tools and methods and experimental planning using design of experiments DoE
Application of QbD principles for process risk evaluation and support process validation
Supervisor and responsible for particular laboratories and equipment dedicated to the work area including contact person for maintenance activities, writing of work and equipment SOPs as well as troubleshooting support
MSc/PhD level in Biotechnology / Biology / Chemistry or equivalent
Minimum 2+ years of successful industry experience in the development of fermentation processes or any other relevant field
Hands-on experience with microbial fermentation at bench and pilot scale
Experience with GMP would be an asset
Know-how on DoE and statistics for study planning and data evaluation
We are looking for a team player and communicative personality

Scientist Product Development Resume Examples & Samples

Execution of various projects, processes and/or initiatives supporting identified strategic direction
Participates in industry sponsored organizations to promote Newpark’s goals
Develops new technologies in the area of drilling fluid’s systems and additives
Actively contributes to the development of best safety practices and standard operating procedures
Writes internal/external technical reports and contributes occasionally through patents, publications or presentations, documenting company technical achievements
Responsible for the development and maintenance of specific core competencies and key supporting technologies
Operates safely in the laboratory environment. Knowledgeable of the chemical hygiene plan and the current laboratory safety standards
Provides technical guidance to others and is consulted by colleagues with a high degree of confidence placed subject matter expertise
Assists in training Mud School(s) and Customer Mud School(s)
Updates Management on project status, opportunities, challenges, etc
Bachelors Degree in Science/Chemistry Field
4-5 yrs experience in oilfield fluids development preferred

Senior Scientist Product Development Resume Examples & Samples

Food technology
Team leadership and project management across functions
Industry safety standards and Good Manufacturing Practices (GMPs)
Good understanding of NPDI, GLOBE specification process and PMD creation

Principal Scientist Mass Spectrometry Research & Development Resume Examples & Samples

Initiate, direct, and execute scientific research with an emphasis on developing next generation technology, trade secrets, and intellectual property
Act as a scientific expert/consultant during product development including implementation and process confirmation phases, assisting in thorough conceptualization and overall design and testing of new products
Design and drive the execution of feasibility, verification and validation studies for the proposed mass spectrometry products according to design control procedures
Influence the scientific community and market via patents, publications, and conference presentations
Provide research project planning and time estimates
Evaluate competitive products and new technologies from research institutions, aiming to enhance future products
Work with manufacturing and service personnel to design for quality, manufacturability, and serviceability of products
Experience and ability to lead and coordinate multiple collaborative projects in a cross-functional program team environment
Master’s degree in science, engineering, or related field (Physics, Chemistry, Engineering, with strong mathematics skills) required, PhD level education is strongly preferred
Experience with triple quadrupole mass spectrometers is strongly preferred
Knowledge in design and development of atmospheric pressure ion sources for liquid chromatography-mass spectrometry LC-MS, gas chromatography (GC) and time-of-flight (TOF) is desirable
Strong instrumentation design skills and troubleshooting ability
Ability to make independent decisions
Ability to dissect problems and projects into manageable tasks
Ability to plan and define research projects
Previous successful academic or work-related experience mentoring peers preferred
Proven track record of publications in peer-reviewed journals

Scientist, Translational Development Resume Examples & Samples

Defining and obtaining data from appropriate cell-based and in vivo disease models
Developing and optimizing clinical-grade assays to analyze drug effect in clinical samples
Identifying patient populations of interest, selecting pharmacodynamic and efficacy biomarkers, optimizing dose and schedule, and determining combination strategy
Informing disease area strategies
Rapidly, effectively, and insightfully progressing novel agents through early safety, efficacy and signal searching studies
Supporting registrational and other late development studies with appropriate patient selection and correlative assays
Providing scientific leadership and correlative biology support for marketed agents
Design and execute experiments independently and with high efficiency and accuracy
Analyze, interpret and present data
Troubleshoot and optimize assays
Train other research associates and scientists in lab assays of expertise
Work with human blood and tissue samples
Actively participate in the development of cell-based assays for mechanistic studies, including biomarker discovery
Interact with manager and project team to review data and plan next steps
Prepare and present work at group meetings
Flexible to changing priorities
Expertise in cell culture of mammalian cell lines, and isolation and culture of human or mouse tissue derived primary cells
Cell-based assays for cell phenotype analysis, growth/viability and signal transduction on cancer cells or immune cells
Measurement and manipulation of gene expression (RT-PCR, si/shRNA, CRISPR/Cas9 gene editing)
Independent data analysis and presentation
Proficient in multiplexed plate based signaling and cytokine assays
Core cell biology skills including flow cytometry, microscopy, Westerns, immunoprecipitation, ELISA etc
Experience with in vivo studies in mice and with CRO management are a plus
Able to independently design experiments to address a scientific question
Self-directed use of literature to inform approaches and experimental methods
First-rate skills in spotting artifacts and troubleshooting assays
Ability to critically assess project strategies and formulate ideas
Solid understanding of scientific mechanisms and experimental techniques, with knowledge of cancer cell biology preferable

Cell Culture Development Senior Scientist Resume Examples & Samples

B.S/M.S. in Biology, Chemical/Biomedical engineering or related discipline with 0 – 2 years industry experience
Candidates must have knowledge of cell culture development processes for the manufacture of monoclonal antibodies or recombinant proteins/vaccines
B.S./M.S. in Biology, Chemical/Biomedical engineering or related discipline with 3 – 5 years industry experience
Basic knowledge and experience in scaling-up cell culture processes from Shaker flasks and WAVE Reactor bags to stirred tank bioreactors is highly desired
Experience in improving cell culture processes by media and feed formulation optimization is preferred
Previous experience with authoring of CMC sections for regulatory filings is preferred
Experience in developing high cell density and high productivity processes by optimizing fed-batch and/or perfusion processes (Alternating Tangential Filtration – ATF) is a plus
Experience with Single Use Bioreactors (SUB) is a plus

Scientist, Oncology Biomarker Development Resume Examples & Samples

Provide exceptional scientific leadership to peers in OBD and assigned project teams
Drive and execute on biomarker strategies for one or more projects
Participate and thrive in an interactive, team oriented culture
Participate in or lead disease focused translational biomarker programs

Scientist Bioassay Development Resume Examples & Samples

Responsible for experimental design, execution, data review and analysis, document writing, and contributing to sections of regulatory submissions. Generate and thoroughly document results, and maintain instrumentation in a GMP-compliant environment
Typically 0-2+ years directly applicable experience in biopharmaceutical development
BIACORE or FACS experience would be advantageous
Methodical, and committed to high-quality results
Awareness of regulatory and compliance guidelines

Global Technology Development Data Scientist Resume Examples & Samples

Provide statistical recommendations on experimental design during the planning stages of field activities
Build statistical models for the analysis of trial data based upon the finalized protocols for rapid analysis post-harvest
Provide clear and understandable validated analysis of trial results to internal customers which drive both strategic decisions, knowledge transfer, and marketing/sales support
Provide value added business recommendations and solutions based on innovative predictive analytics to accelerate product development and characterization
Apply statistical principles which maximize the predictive power of trial results including sample size, power calculations, trial design, and placement of experiments
Ensure quality control processes are established for verification and validation of data
Partner with IT teams to ensure data stewardship best practices are followed across data systems and processes from data entry through reporting
Develop and validate data cleansing, processing, and QA/QC procedures for the handling of spatially referenced data layers to increase understanding of the complex relationships between hybrid product performance and the environmental factors which influence such performance
M.S. or Ph.D. in statistics, data science or other related quantitative field with heavy emphasis on statistic
3+ years of experience with statistical programming packages (R, Matlab, SAS, JMP, etc.)
Demonstrated excellence in presentation and communication skills
Experience in both statistical analysis and agricultural field research with knowledge of key cropping systems
Expertise in a wide range of statistical techniques including, but not limited to experimental design, linear and non-linear mixed models, multivariate statistics, non-parametric analysis, and Bayesian statistics
Proficiency with data mining techniques and applications to identify patterns from large datasets
Experience in data management, summarization, and interpretation of data
Ability to prioritize and deliver across requests from multiple teams
Understanding of machine learning algorithms and building predictive models
Willing to travel internationally as needed
Experience with geospatial analysis and related programs (ArcGIS or QGIS)
Experience modeling environmental data, including soils and weather data, especially for understanding genotypic interactions with environment
Strong foresight, planning, prioritization, and organization skills
Ability to lead and influence activities of cross-functional teams without direct reporting relationships
Experience with data flow (data stewardship) through multiple, integrated data system
Understanding of IT and database management

Senior Scientist, Method Development Resume Examples & Samples

Function independently as a MD Senior Scientist in the direction and execution of assigned studies in compliance with GLP/GCP regulations as they apply to the conduct of non-clinical and clinical research. The Senior Scientist may also be required to execute bench duties based on resource availabilities
Participate, when required, in the proposal management and quote development process along with Scientific Director and Business Development team, serving as a key scientific contact for new and existing business partners
Participate in Sponsor/Client update meetings, along with various Intertek internal stake-holders
Design and analyze experiments in accordance to SOPs and other industry guiding documents and assure appropriateness of immunoassay methods to stage of sponsor drug development process
Review, interpret, integrate, and present data on assigned studies
Function independently as contact for the planning and execution of sponsor interaction related to assigned studies, including scheduling and conducting of experiments
Provide oversight of the laboratory and mentor technical staff in areas such as protocol interpretation, method development and refinement, study-related problem resolution, and method validation. Provide scientific expertise in study conduct, design, and interpretation
Monitor performance of direct reports. Provide regular coaching and counseling for career development
Perform all other related duties as assigned
Ph.D. with a minimum of 1-2 years of experience working in a regulated industry environment (GLP/GMP/CLIA)
Master’s Degree in Science with a minimum of 6-7 years of industry experience, including at least 4 years of experience working in a regulated environment (GLP/GMP/CLIA) supporting large molecule drug development
Bachelor’s Degree in Science with a minimum of 7-8 years of industry experience, including at least 7 years of experience working in a regulated environment (GLP/GMP/CLIA) supporting large molecule drug development
Proven knowledge of applied immunoassay techniques through previously developed and validated immunoassay methods in support of protein therapeutic pharmacokinetic and multi-tiered immunogenicity assays on various technology platforms such as ELISA, Meso-Scale Discovery and Luminex
Previous experience applying immunoassay techniques in support of GMP compliant CMC potency assays and fit-for-purpose drug development biomarker programs is an added plus
Effective written and verbal communication skills (industry related, e.g., posters, presentations, publications)
Leadership role in in client meetings and communications
Ability to manage multiple projects, prioritize work, and meet deadlines
Proficiency in the use of standard software including Microsoft® Excel, Word, PowerPoint, etc., and with standard laboratory calculations
Use of SoftMax and Watson LIMS is added plus

Bioprocess Technology Development Senior Scientist Resume Examples & Samples

B.S./M.S. in chemical engineering, biochemical engineering, bioinformatics, or a related discipline with 5-10 years of industry experience
Experience with multivariate analysis (e.g., PCA, PLS) of large data sets or other innovative bioinformatics or modeling techniques
Skills related to process analytical technologies such as Raman spectroscopy, including chemometrics
Experience evaluating and implementing new platform technologies
Hands-on mammalian or microbial bioreactor experience

Principal Scientist Assay Development Resume Examples & Samples

Pharmaceutical/biotechnology industry experience in drug discovery in neuroscience or cardiovascular disorders
Previous experience in the management & mentorship of more-junior scientific staff and a demonstrated ability to build & lead a small and efficient team
A thorough practical & theoretical understanding of the principles of structure-function relationships, molecular biology, physiology & pharmacology of diverse target classes and an ability to apply this knowledge to resolve scientific & technical challenges on early-stage drug discovery projects
Deep expertise in protein & cellular reagent generation & qualification as well as broad experience in the independent development & implementation of cell-based (e.g., second messenger, reporter gene) and biochemical (e.g., radioligand binding, protein-protein interactions, enzymatic activity, protein modifications) assays for multiple target classes
Advanced experience in the operation of fluorescence/luminescence microtiter plate readers (e.g., FLIPR, EnVision, TopCount) and automated liquid handling systems (e.g., Bravo, Vprep, Echo, Washer/Dispenser II) in the context of HTS, hit characterization & lead optimization in 384- or 1536-well microtiter plate format
A keen awareness of new & emerging technologies for bioassays, including custom assays & reagents as well as novel liquid handling & detection hardware
Advanced experience in handling & manipulating large data sets using analysis software such as Screener, Spotfire, Pipeline Pilot
Proven ability to design & execute creative, high quality experiments independently and to interpret, explain & communicate results in a fast-paced team environment while paying attention to project timelines & priorities
Highly motivated, innovative, proactive & enthusiastic team player demonstrating flexibility, a willingness to learn & a great sense of urgency
An ability to prioritize effectively & utilize resources efficiently coupled with strong organizational, interpersonal as well as verbal & written communication skills

Scientist, R&d-product Development Resume Examples & Samples

Manage multiple assignments/research projects concurrently and possess the ability to call out priority conflicts between a variety of business initiatives
BS/MS in Food, Dairy, Meat, Animal Science, or Chemical Engineering
Minimum of 2 years in a Technical Function (which can include all graduate and/or internship work)
Ability to lead, coach and motivate others
Strong understanding of Design of Experiments

Scientist / Development Resume Examples & Samples

Masters in biological sciences with 8+ years’ experience in oncology drug development and translational science
Expertise in cancer biology and cancer immunology, specifically in lymphoma
Expertise in the integration of preclinical research and clinical drug development
Ability to develop, lead and execute clinical correlative science strategies
Management experience with the ability to set priorities, direct projects and implement complex strategies
Able to communicate in both written and verbal format complex and detailed information in a manner that enhances understanding and ensures that the recipient will be able to apply the information presented

Scientist, Cancer Diagnostics Development Resume Examples & Samples

Demonstration of excellent communication and teamwork skills
Proven proficiency in biology techniques including: immunohistochemistry, in situ hybridization, fluorescent techniques, protein biochemistry; cell biology and molecular biology a plus
Strong quantitative data analysis skills
Ability to work independently with speed and focus
Minimum of 2 years laboratory experience in biology and/or biochemistry
Minimum requirement MS in Biology or Biochemistry, Ph.D. preferred

Scientist, Purification Development Resume Examples & Samples

Plans own weekly activities with input in accordance with group/lab objectives and priorities
Regularly exercises technical discretion in the design (DOE), execution, and interpretation of experiments that contribute to project goals
Has understanding and ability to apply established principles and concepts of protein purification
Investigates, creates, and develops new methods and technologies to support project needs
Develops and optimizes chromatography and filtration processes
Works independently with minimal supervision and within the framework of a multidisciplinary science team
Authors development and optimization study protocols and reports in a GLP fashion to support drug development and process improvement, as well as regulatory filings
Presents study results to technical operations and science teams in written and oral formats
Hands on experience with bench scale chromatography systems
Ability to work independently as well as in a team
Flexibility to work on multiple disciplines (e.g. purification and cell culture)

Product Development Senior Scientist Performance Resume Examples & Samples

Drive automotive product development from concept to launch (formula development through to technology transfer)
Work with marketing, sales, and regulatory in developing competitive claims and product demonstrations
Work closely with other RD&E functions like packaging and process to develop holistic solutions to bring products to market
Define and use SOPs, best practices, experimental designs and test methods to ensure a robust and rigorous development process
Analyze, interpret and present data to meet project targets and objectives. Make recommendations that drive efficiency and manage risk
Develop and maintain professional relationships with suppliers, technical experts etc. Identify and drive capability and process improvements to enable more efficient product development
Design and execute project work against discovery/contract objective
BS/MS/PhD in Chemistry, Chemical Engineering or equivalent discipline
2-5+ years of formulation experience
Experience in automotive performance chemistry and products is desired
Demonstrated strong leadership and influencing skills

Scientist, Sterile Product Development Resume Examples & Samples

Participate in media fills for aseptic fill projects Assist in the equipment set up, operation, maintenance, cleaning as required for the project
Perform environmental monitoring of manufacturing areas per applicable SOPs and maintain records Assist with manufacturing area maintenance such as area monitoring and qualification, purchase of gowning supplies, purchase of equipment and room cleaning supplies, microbiological monitoring supplies Maintain records for personnel gowning qualification
Assist lead formulators in activities such as but not limited to, material procurement, data recording and compilation Interact/collaborate with other groups/functions (Formulators, Analytical Scientists, Quality Assurance, Material Coordinator, Manufacturing Technicians) to facilitate transfer of knowledge and delivery of drug product

Scientist, Bioassay Development Resume Examples & Samples

Directly accountable for bioassay development for early and late stage development programs, development of fit-for-purpose biological characterization assays, assay qualification/validation, lot release and stability analysis, and strong collaboration with stakeholders in partner organizations
Responsible for experimental design, execution, data review and analysis/interpretation, and document authorship
Generates and thoroughly documents results, and maintains instrumentation in a GMP-compliant environment
Inspires innovation and operational excellence and fosters a continuous learning environment
Typically MS in immunology, cell biology, molecular biology or equivalent field with 3-5 years’ experience, or BS with 5-10 years’ experience
Experience with the development of cell based in-vitro assays
Experience in ELISA development
BIAcore/SPR and/or FACS experience is advantageous
Methodical and committed to high-quality results
Strong scientific, interpersonal and communication skills
Awareness of regulatory and compliance guidelines would be advantageous

Scientist, Bioassay Development Resume Examples & Samples

Directly accountable for the development and execution of BIAcore/SPR methods for the characterization of protein-protein interactions
Directly accountable for bioassay development for early and late stage development programs, development of fit-for-purpose biological characterization assays, assay qualification/validation, and strong collaboration with stakeholders in partner organizations
Responsible for experimental design, execution, data review and analysis/interpretation, document writing, and contributing to sections of regulatory submissions
Participates in development of the analytical control strategy and anticipates and addresses technical, regulatory, and other business needs
Generate and thoroughly document results
In exceptional cases, non-PhD candidates with significant relevant experience may also be considered
Expertise with quantitative analysis of protein-protein interactions using BIAcore surface plasmon resonance (SPR), including kinetics and affinity as it relates to understanding mechanism of action/functionality
Experience in cell-based in-vitro assays functionally related to molecular and/or clinical mechanism of action of biotherapeutics would be advantageous
Awareness of regulatory guidelines would be an asset but is not required

Product Development Senior Scientist Resume Examples & Samples

Utilize advanced technical skills to successfully translate consumer needs and industry trends to robust technical approaches and apply technology and solutions from both inside Spectrum Brands and outside sources to deliver superior products
Champion ideas through the Discovery phase; lead, design and execute project work against contract objectives with consumer guidance central to the approach
Develop reproducible, relevant test methods to evaluate prototypes and competitive products
Work with marketing, sales, and regulatory in supporting competitive claims and developing product demonstrations
Be the technical category expert by performing competitive assessments, identifying and evaluating new products on the market, and providing new product alerts to appropriate internal business partners
Partner closley with other RD&E functions like packaging and process to develop holistic solutions to bring new products to market
Work closely with procurement to Identify and evaluate new technologies and prototypes from suppliers and co-packers
Analyze and interpret data to meet project targets and objectives, and make recommendations that drive efficiency and manage risk
Maintain lab instruments/equipment and raw material inventory
Manage technicians and provide direction and prioritization of workload
Develop and maintain professional relationships with suppliers, technical experts etc
Identify and drive capability and process improvements to enable more efficient product development
Drive the creation of a broad exclusionary strategy (IP) when/where applicable
BS/MS/PhD in Chemistry, Chemical Engineering or equivalent discipline and 5+ years of formulation experience
Demonstrated strong technical and people leadership and influencing skills
Excellent organization skills with the ability to handle multiple projects simultaneously and effectively
Confident self-starter, capable of working cross-functionally in a fast paced environment
Expertise in formulation chemistry, raw materials, surfactants, and the ability to use this knowledge to develop innovative, cost effective products

Senior Scientist, R&D Product Development Resume Examples & Samples

Autonomously leads projects of complex scope
Work with cross functional teams to execute projects across all the BU's
Demonstrates strategic thinking and can influence business direction
Trains/coaches junior members of the organization
Technical expertise demonstrated
Communicates effectively to the cross functional teams with very little guidance and can provide recommendations/appropriately communicate risk
Execute product testing, qualification and commercialization while working closely with cross-functional team members in laboratory and production environments

Senior Scientist, R&D Product Development Resume Examples & Samples

Work with cross functional teams to identify, scope and develop Cost Engineering opportunities
Strong, demonstrated ability to learn new product categories and/or processing/packaging areas
Minimum of 5 years in a Technical Function (which can include all graduate work)
Strong understanding of ingredient functionality and interrelationship of ingredients, process, and packaging
Manage multiple assignments/tasks concurrently with the ability to prioritize work
Excellent understanding of Design of Experiments

Antibody Development Senior Scientist Resume Examples & Samples

Team-working focus and excellent communications and inter-personal skills
Great command in English, computer skills, well-organized, details-orientated, and self-motivated
Ability to process and communicate complex scientific information through verbal discussion, presentation or in writing
PhD in biology, biochemistry, immunology, or a related field and a minimum of 2 years (after PhD) of relevant working experience is required
Broad experience in hybridoma or display technologies is highly desired
Knowledge of a full range of characterization of antibodies including epitope mapping, bioanalytical characterization, and immunogenicity analysis
Familiar with antibody engineering would be a plus

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