Scientist, Process Development Resume Samples

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T Mitchell

Trey

Mitchell

8179 Willie Orchard

Philadelphia

+1 (555) 776 4093

8179 Willie Orchard

Philadelphia

Phone

p +1 (555) 776 4093

Experience Experience

Phoenix, AZ

Scientist Upstream Process Development

Phoenix, AZ

Gorczany, Leuschke and Bosco

Phoenix, AZ

Scientist Upstream Process Development

Knowledge of cGMPs as applied to process development and scale up
Recommend innovative new technologies and perform the necessary experiments for evaluation and implementation
Prepare/review technical documents including development /tech transfer reports, batch records, SOPs and CMC regulatory submissions
Recommend innovative new technologies and perform the necessary experiments for evaluation, implementation and writing scientific publications
Drive innovation and continuous improvement by conducting laboratory experiments to evaluate new bioprocess technologies
Develop and implement molecular cell biology tools or assays to characterize cell physiology changes and correlate to cell culture performance or product quality attributes
Work in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies for fermentation processes. Provide technical guidance in scale up programs based on risk assessment of critical parameters and their impact on product quality attributes

Los Angeles, CA

Scientist, Downstream Process Development

Los Angeles, CA

Wisoky LLC

Los Angeles, CA

Scientist, Downstream Process Development

Performs viral clearance validation and scale down models for biopharmaceutical processes, including review and interpretation of results (including off-site)
Updates group members on background and status of client projects by giving oral updates or internal presentations
Researches and develops existing and new technologies/process improvements
Performs lab overview for client tours and internal clients (shadowing)
Maintains documentation of experiments and/or batch records according to good documentation practices
Accurately reviews batch records and other data, ensuring consistency
Initiates, directs and executes scientific research for innovation and process improvements

present

Los Angeles, CA

Senior Scientist, Process Development

Los Angeles, CA

Parker Inc

present

Los Angeles, CA

Senior Scientist, Process Development

present

Understands and applies principles of biosafety to maintain a safe workplace for self and others
Design and execute innovative process development and characterization activities, impurity and viral clearance studies
Provide project update, analysis and advice to cross-functional team and senior management
Reviews worksheets and batch records
Contributes to operations of the process development lab, including training of new employees
Present original work internally across departments and divisions, and at external conferences
Develop recovery and purification process that utilizes clarification, chromatography, and membrane filtration technologies for recombinant proteins

Education Education

Bachelor’s Degree in Autonomy

Washington State University

Bachelor’s Degree in Autonomy

Skills Skills

Responsible for successful process development and technology transfer of Cell and Gene Therapy products. Areas of focus include culture of adherent and suspension primary cells, cell strains, and immortalized cell lines, downstream processing of cell products, production of viral vectors, and downstream processing of viral vectors
Applies understanding of the scientific fundamentals of cell culture and purification unit operations used in cell and gene therapy manufacturing to develop and justify development strategies and experimental designs
Serves as a technical lead for process transfer of projects to GMP production facilities. Also responsible for experimental design of process development studies, applying and Design of Experiment methodologies where appropriate
Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments applying Quality by Design principles where appropriate
Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes. Serves as an internal subject matter expert (SME)
Contributes to operations of Process development team by contributing to development and implementation of business and laboratory systems /processes to support core business activities
Reviews laboratory worksheets and batch records
Responsible for training new employees on areas of technical expertise and compliance issues relevant to the lab setting
Understands and applies principles of biosafety to maintain a safe workplace for self and others
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures

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Process Development & Automation Scientist Resume Examples & Samples

Master's or Bachelor's Degree
2-3 years relevant experience in cell culture, process development, and microfluidics
Excellent documentation, communication, and organizational skills
Able to work productively in a highly-collaborative, team-oriented environment

Process Development NPI & Product Scientist Resume Examples & Samples

Knowledge of cGMP's and other worldwide regulatory requirements
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability
Strong knowledge of Quality systems, Drug Product Manufacturing and Validation
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role

Scientist, Purification Process Development Resume Examples & Samples

Leading and participating in design of experiments, executing the planned experiments, optimizing purification process steps, and data analysis for early and late stage products
Lead the design and execution of the development studies to identify and determine process parameter ranges for purification process steps
Provide technical leadership to others and make decision to set directon for a project
Take a lead role to transfer process from development to GMP clinical and commercial manufacturing
A PhD in Chemical Engineering or Biological Sciences or Biochemistry with relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 5 years of relevant experience OR a BS in Chemical Engineering or Biological Sciences or Biochemistry and with at least 7 years of relevant experience is required
Broad knowledge in purification process development and hands-on experience in one or more of the purification process development steps – cell recovery, chromatography operations, and UF/DF is required
Previous experience in scale-up and transfer of a purification process to clinical and commercial GMP manufacturing is preferred
Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of recombinant proteins and/or virus is preferred
The ability to report data, present findings to management is required
Experience with team-based collaborations is required

Scientist, Process Development Resume Examples & Samples

Perform development, scale up and transfer of cell culture and purification processes to GMP Production
Expectations to keep excellent laboratory records
B.S. or M.Sc. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology or related programs with 2-5 years of relevant experience, depending on degree held
Ability of scientific independent thinking and to design and perform experiments
Good interpersonal and communication/writing skills
Ability to work in teams is critical
Familiarity with cell culture in flasks, wave bags and bioreactors and media/buffer preparation

Scientist Upstream Process Development Resume Examples & Samples

Hands-on operation of lab scale bioreactors for mammalian cell culture processes
Upstream process design, optimization, and tech transfer to clinical manufacturing
Prepare/review technical documents including development /tech transfer reports, batch records, SOPs and CMC regulatory submissions
Participate on cross functional teams to progress both early and late stage drug candidates
Train junior team members in lab operations
Recommend innovative new technologies and perform the necessary experiments for evaluation and implementation
Develop and implement molecular cell biology tools or assays to characterize cell physiology changes and correlate to cell culture performance or product quality attributes
PhD or Masters in Chemical/Biochemical Engineering, Biochemistry, Biophysics, Cell Biology or related field with 0–2 or 4– 6 years, respectively, of relevant industrial and/or academic experience preferred
In depth understanding and hands on experience in upstream process development, bioreactor operation and scale- up/down, media development
Practical experience with downstream processing or analytical techniques relating to glycoprotein attributes
Knowledge of statistical experimental design and data analysis
Knowledge of cGMPs as applied to process development and scale up
1603488

Scientist, Downstream Process Development Resume Examples & Samples

Initiates, directs and executes scientific research for innovation and process improvements
Acts as the technical lead for client development projects (including DOE), communicates project status and effectively provides technical explanation/rationalization
Writes complex procedural SOPs, batch production records and reports
Executes purification experiments including automated chromatography (AKTA platform), filtration, clarification, column packing, and tangential flow filtration independently
Demonstrates expert knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography
Maintains documentation of experiments and/or batch records according to good documentation practices
Demonstrates expert knowledge of scale up principles with respect to purification and filtration
Performs viral clearance validation and scale down models for biopharmaceutical processes, including review and interpretation of results (including off-site)
Participates in technology transfer of processes to a cGMP facility, with support from Supervisor or Sr. Scientist
Maintains project timelines
Troubleshoots and problem solves to initiate and execute/monitor corrective actions
Accurately completes routine and preventative maintenance on laboratory equipment
Aseptic technique experience
Process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow) experience
Experience with viral clearance validation, scale up, and technology transfer
Operating, maintaining, and troubleshooting chromatography work stations and process skids preferably in an industrial setting
Experience writing standard operating procedures, batch records, and reports
Direct Reports: N/A
Total Site Staff (includes directs): N/A

Scientist, Upstream Process Development Resume Examples & Samples

Researches and develops existing and new technologies/process improvements
Accurately reviews batch records and other data, ensuring consistency
Accurately ships media samples to clients and fills out appropriate paperwork
Maintains the mammalian cell lines to be used in process development
Troubleshoot and problem solve in order to initiate and execute/monitor corrective actions
Actively participates in team meetings
Good documentation practices (GDP)

Scientist, Downstream Process Development Resume Examples & Samples

Responsibilities will include, but are not limited to, the following
Perform downstream protein purification process development and process optimization of large molecule/recombinant proteins from traditional cell culture, microbial fermentation, or new and unconventional bioprocesses, including second generation therapeutic antibodies, antibody-drug conjugates, bi-specific antibodies and fusion proteins
Conduct all aspects of downstream process unit operations, including conjugation and other reactions, centrifugation, depth filtration, chromatography, TFF, viral inactivation and viral filtration
Develop robust and scalable protein purification processes for Celgene biologics candidates
Execute process scale up and transfer to CMOs for cGMP production
Develop downstream platform process including harvest/clarification, chromatography purification and UF/DF processes for Celgene biologics programs
Develop high throughput screening methods and new technologies for process/method improvement
Develop and perform analytical methods for in-process sample testing to support biologics early-phase process development and small/ pilot scale production
Work closely with cell-line development, upstream process development, analytical and formulation development groups to support discovery and preclinical development activities
Supervise and train associates
Work collaboratively with external partners to manage early development programs and outsourced activities
Write technical reports and present data/results to the project teams
Skills/Knowledge Required
Hands-on experience with continuous flow centrifugation, tangential flow filtration, and AKTA purification with preparative chromatography systems and Unicorn software
Experience with process scale-up and technology transfer from development lab to pilot plant and into cGMP facilities
Experience with HPLC/UPLC practical analytical chromatography, spectrophotometry, SDS-PAGE, Western-blot and ELISA methods
Can adopt strong scientific and engineering approaches to problem solving and process development and optimization
Able to introduce new technologies to improve and accelerate downstream process development and improve process efficiency
Knowledge of scale down model qualification, process optimization with risk analysis, FMEA methodology, and process characterization. Use of statistical experimental design and data analysis
Knowledge and/or experience with automation experience in process setting and supervision is a plus
Demonstrated ability to function in a collaborative/team oriented R&D environment
Able to communicate and connect with all levels of the organization

Research Scientist, Process Development Resume Examples & Samples

Becomes familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision
Works under supervision of more senior scientists or scientific directors to advance the development of economical, state-of-the-art techniques to isolate, characterize, purify and mass-produce substances
Advises members of project teams in the initiation and execution of laboratory experimentation, considering various factors
Demonstrates excellent communication skills (both verbal and technical) and strong interpersonal skills
Demonstrates collaborative communication and problem solving spirit
Requires a PhD in Organic Chemistry/Chemistry with a minimum of 2 years of related industrial or postdoctoral experience

Research Scientist, Process Development Resume Examples & Samples

Familiar with Pilot Plant operations and able to write master batch records and safety summaries with limited supervision
Pays particular attention to avoiding reactions and processes that do not scale well, such as distilling to dryness and flash chromatography
May suggest alternative chemistry including step optimization and new route selection
Gains a better understanding of how impurities are formed, tracked and purged throughout the subsequent processing
Works in collaboration with more senior scientists or scientific directors to advance the development of economical, state-of-the-art techniques to isolate, characterize, purify and mass-produce substances
Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity
Advises members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors
Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the direction that supports Company interests
Demonstrates excellent verbal communication skills and interpersonal skills
Requires a PhD in Chemistry with a minimum of 4 years of experience in chemical process development for pharmaceuticals
Process Development: 4 years

Scientist Process Development & Engineering Resume Examples & Samples

Experience in cell culture medium development
Ability to apply statistical designs and analyses to develop new media to improve mammalian cell culture processes
Strong skills in critical thinking, laboratory experimentation and data analysis. Ability to multitask and maintain organized data systems
Strong communication and interpersonal skills to work in team environment

Scientist Process Transfer & Development Resume Examples & Samples

Champion continuous improvement activities by initiating process and product quality improvement initiatives
Good understanding of Upstream processing
Experience developing, scaling and transferring the following upstream unit operations: thaw, expansion, production bioreactor, cell harvest & clarification
Demonstrated ability to lead and influence in a collaborative, matrixed, and customer focused environment
Upstream biologics development and manufacturing
Technical transfer of upstream processes
Scale-up/scale-down of upstream processes
CGMP manufacturing
CGMP document preparation, proficiency in Microsoft Word
BoM development, proficiency in Microsoft Office
Media and Feed Studies
Harvest and Clarification Studies
GE/Xcellerex XDM Bioreactor system experience a plus
Amber system experience a plus
Upstream single-use technologies

Scientist Upstream Process Development Resume Examples & Samples

Apply an advanced knowledge of biological manufacturing science in the design and execution of bioreactor experiments to identify and validate critical parameters that affect upstream bioprocess performance across multiple scales. The parameters to be investigated include reactor configuration, medium formulation, and fed-batch strategies
Systematically optimize the parameters that affect bioreactor performance through the application of statistical models for experimental design and analysis
Work in collaboration with colleagues in pilot and manufacturing scale operations to devise scale-up strategies for fermentation processes. Provide technical guidance in scale up programs based on risk assessment of critical parameters and their impact on product quality attributes
Serve as a technical resource to project teams by providing the essential expertise in biological manufacturing science required for successful project delivery. This includes a willingness to share experimental findings with team members, peers, and management
Document experimental findings through periodic authorship of progress reports that will be included in dossiers for product registration and technology transfer. Serve as a technical expert to project teams
BSc, MSc, or PhD in microbiology, cell biology and physiology, chemical or biochemical engineering with 2-5 years experience in the industry for bioprocess development for manufacturing of high-value biological products
Demonstrated track record as an researcher working in the field of bioprocess development
Comprehensive hands-on practical experience with one or more systems involving cultivation of wild type micro-organisms, yeasts, or prokaryotes for recombinant protein expression. Advanced knowledge in the design and optimization of these systems to deliver cost-effective and robust manufacture of antigens or recombinant proteins in accord with the requirements of GMP
Excellent aseptic technique
Demonstrated track record working as an scientific collaborator on multiple concurrent programs
A willingness to embrace and evaluate new technologies for the purpose to improve existing capabilities and workflows within the line

Principal Scientist Downstream Process Development Resume Examples & Samples

Knowledge of purification processes for the production of therapeutic proteins
Experience in scale down qualification of purification unit operations
Experience in early and late stage process development for therapeutic proteins
Possess strong scientific skills including sound experimental design, data processing and interpretation skills
Demonstrated experimental design with DOE approaches
Fast learner with an attention to details
Experience with external collaboration and in team environment
Exposure to and awareness of external scientific field and trends as they relate to biologics process development; including therapeutic protein process and product technologies

Scientist, Upstream Process Development Resume Examples & Samples

Ph.D. in Biotechnology, or related field with at least 2 years of laboratory experience, preferably in an industrial setting
MS in Biotechnology or related field with at least 3 years of industry laboratory experience
B.S/B.A. in Biotechnology, or related field with at least 5 - 8 years of industry laboratory experience
Associates Degree/Certificate/Diploma in laboratory science with at least 7 years of industry laboratory experience

Scientist Assay Process Development Resume Examples & Samples

BS or MS Chemical Engineering, Chemistry, Materials Science, Biomedical Engineering, Mechanical Engineering or related discipline
Masters degree with 2-3 years of relevant experience
Bachelors degree with 5 years of relevant experience
Prior experience with consumables manufacture engineering and related problem solving
Knowledge of membrane and filter materials, properties, and suppliers
Operation of Biodot, Nordson or similar printing technologies
Analytical background with strong problem-solving skills and innovative mindset
Knowledge of Six Sigma / Lean Manufacturing tools

Scientist, Process Development Resume Examples & Samples

Apply Par approved evaluation and validation practices and policies to all Technical Operations projects
Assist with optimization of Par's manufacturing processes
Write protocols and or change requests for evaluation and validation studies, write reports for describing all executed work and write and/or update department SOP's as needed
Maintain the technical services/validation library
Keep abreast of changing regulatory requirements (guidance) and industry practices for drug development and manufacturing
Number of exempt employees supervised: 0
Bachelors degree in relevant science or engineering
3 - 6 years-related experience in the pharmaceutical industry
Familiarity with statistics and PC (Word and Excel) preferred
Must be able to stand for extended periods of time
Must be able to lift containers of up to 50lbs
Must be able to work while wearing respirators and face masks

Scientist Late Stage Formulation & Process Development Biologicals Resume Examples & Samples

As Scientist you lead and coordinate pharmaceutical development activities (formulation, pharmaceutical processes incl. transfers) with a focus on late stage for parenteral dosage forms of NBEs and Biosimilars
Within the respective CMC Team you represent drug product development and lead intermittent or support the multidisciplinary drug product team
You ensure delivery of drug product work packages and project support according to project objectives, timelines and cost
You ensure delivery of high quality data, presentations and reports including required documentation for regulatory filings
Regarding stakeholders you ensure excellent communication (e.g. project team and line management), excellent interaction and collaboration with interfaces (e.g. manufacturing sites)
You identify, evaluate and implement new technologies for formulation and process development or related protein analysis including supervision of students
You contribute to laboratory team capability development, process improvements and `BI safe` concept
Moreover, you enable and support lab team in detailed planning, execution and interpretation of experiments

Scientist Process & Transfer Development Resume Examples & Samples

An B.S./M.S./Ph.D. degree in Biology, Biochemistry, BioManufacturing or Chemical Engineering
5+ years relevant work experience
Good understanding of Downstream processing
Experience developing, scaling and transferring the following downstream unit operations: cell harvest clarification, chromatography, filtration, viral filtration, depth filtration, UFDF, membrane chromatography
Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
Bachelors degree in Life Sciences, Chemistry, Physics, Biomedical Engineering or related field
1 year relevant work experience
Masters degree in Life Sciences, Chemistry, Physics, Biomedical Engineering or related field
Demonstrated record of innovation in the area of scientific expertise
Experience with research collaborations
Biologics downstream development and manufacturing
Technical transfer of downstream processes
Scale-up/scale-down of downstream processes
CGMP document preparation
Viral clearance studies
GE AKTA chromatography systems and Unicorn software
Downstream single-use technologies

Senior Scientist Process Development Resume Examples & Samples

Operate an independent laboratory that is responsible for the routine preparation of monoclonal antibodies (cell culture and purification) to supply materials for clinical, development, formulation, and analytical needs, primarily in CHO mammalian cell systems
Provide guidance, direction, and education for one or two contract workers who will assist with the cell culture and purification of monoclonal antibody preparations predominantly from CHO cell cultures
Coordinate with the cell culture and downstream development groups to continually update the procedures used for each monoclonal antibody preparation so that it is in line with the current platform process and/or modified as necessary for a particular mAb
Coordinate with mAb PTL’s, early research scientists, clinical, DSP, analytical, and formulation scientists to maintain and publish a schedule of upcoming preparations
As time permits work with cell culture and downstream development groups to perform process characterization studies on process steps (including DOE approaches) to identify and define proven acceptable parameter ranges and normal operating ranges
As requested, work with pilot and manufacturing colleagues to successfully transfer developed processes to a commercial environment
Author protocols, study reports, and technology transfer documents that will support technology transfer within the company or to contract manufacturers and well as to support regulatory filings for new product registrations
Represent the Monoclonal Antibody preparation group on interdisciplinary project teams. Contribute at the technical level to the direction of the team and guide decision making in the context of supply of antibody preparations
Strive for continuous improvement by streamlining existing workflows to increase the volume of work performed by the function while identifying opportunities to shorten the timelines for preparation of supplies
BSc, MSc, or PhD in Biochemistry, Molecular Biology, Biotechnology, Cell Biology, chemical or biochemical engineering, or a related discipline. The successful BSc candidate would be expected to have >7 years of industry experience in biotechnology, the MSc candidate 2-5 years, and the PhD candidate 0-5 years
Demonstrated track record as an independent researcher working in the field of biotechnology
Strong theoretical knowledge in the scientific disciplines that support cell culture and downstream processing such as molecular biology, microbiology, cell physiology, protein chemistry, biotechnology, biochemical engineering and biochemistry
Comprehensive hands-on practical experience with one or more systems for monoclonal antibody expression in either CHO mammalian cells, recombinant protein expression in prokaryotes, or in yeasts
Applied experience in the tools used for growing and purifying monoclonal antibodies including bioreactors and SUBs, multiple modalities of chromatography, cross-flow and dead-end filtration
Preferred experience in upstream space to include hands on work shake flask, small scale bioreactor systems (such as AMBR), bench top bioreactors and larger scale bioreactor systems up to 50L
Experience with in-process analytical systems to monitor and control bioreactor experiments such as cell counting, metabolite profiling, and protein quantification
Practical experience with automated chromatography software such as Unicorn (AKTA Explorer, Pure, and/or Pilot)
Experience in scaling up bioreactor systems and technical transfer into manufacturing operations
Excellent organizational and people skills including the ability to manage several contract employees
Demonstrated record of working in a team environment

Senior Scientist Process Development Resume Examples & Samples

Independently develop and optimize robust, economical purification processes for recombinant proteins and monoclonal antibodies
Work with pilot and manufacturing colleagues to successfully transfer developed processes to a commercial environment
Perform process characterization studies on process steps (including DOE approaches) to identify and define proven acceptable parameter ranges and normal operating ranges
Understand and design viral inactivation/removal processes and work with vendors as necessary to preform viral clearance studies
Serve as a process expert for chromatography and filtration (cross-flow and dead-end) approaches as they pertain to both therapeutic proteins and vaccines
Perform antigen purification and/or viral concentration to support mono- and multivalent vaccine development
Represent DSP and Process Development on interdisciplinary project teams. Contribute at the technical level to the direction of the team and guide decision making in the context of DSP or process development as a whole
Coach and mentor junior Zoetis colleagues and provide direction to contingent workers and contractors providing support for DSP operations
Strive for continuous improvement by streamlining existing workflows to increase the volume of DSP work performed by the function while identifying opportunities to shorten the timelines for process development
Experience with protein modification and/or detoxification of toxins is highly desirable
Experience with isolation of inclusion bodies and protein folding is highly desirable
BSc, MSc, or PhD in Biochemistry, Biotechnology, chemical or biochemical engineering, or a related discipline. The successful BSc candidate would be expected to have >7 years of industry experience in DSP, the MSc candidate 2-5 years, and the PhD candidate 0-5 years
Demonstrated track record as an independent researcher working in the field of protein chemistry
Strong theoretical knowledge in the scientific disciplines that support downstream processing such as protein chemistry, biotechnology, and biochemistry
Comprehensive hands-on practical experience in the tools used for downstream processing including multiple modalities of chromatography, cross-flow and dead-end filtration, cell disruption and removal, and supporting analytical techniques including UV-Vis spectrophotometry, gel electrophoresis, HPLC, and protein assays
Demonstrated track record in developing purification processes for monoclonal antibodies and/or recombinant proteins
Demonstrated record of working in a team environment with highly developed interpersonal relationship skills

Scientist Within Primary Packaging & Process Development Parenterals Resume Examples & Samples

You support packaging development activities for sterile, parenteral dosage forms and related combination products (vials, syringes, cartridges)
You drive parenteral projects for NBEs, NCEs and Biosimilars to support product development including submission on a global basis
Within the respective R&D sub-teams you represent primary packaging development and lead the drug product working team
You plan, execute and interpret experiments for primary packaging of NBEs, NCEs and Biosimilars including prefilled syringe and other parenteral combination products
As a Scientist within Primary Packaging & Process Development Parenterals you transfer primary packaging development activities to operations
You support the documentation for submission in respect to primary packaging (IND/CTA, MAA/BLA)
Furthermore, you evaluate new primary packaging technologies on a scientific basis

Scientist, Upstream Process Development Resume Examples & Samples

At least two years (2) of experience in biotechnology-related position (vaccines and/or therapeutic proteins) after graduation
Must have the ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Excellent organization, interpersonal, verbal and written communication skills

Senior Scientist, Process Development Resume Examples & Samples

Responsible for successful process development and technology transfer of Cell and Gene Therapy products. Areas of focus include culture of adherent and suspension primary cells, cell strains, and immortalized cell lines, downstream processing of cell products, production of viral vectors, and downstream processing of viral vectors
Serves as a technical lead for process transfer of projects to GMP production facilities. Also responsible for experimental design of process development studies, applying and Design of Experiment methodologies where appropriate
Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments applying Quality by Design principles where appropriate
Responsible for activities required for successful operation of assigned project area including: Writing detailed experimental protocols, coordinating activities in the laboratory, developing Bill of Materials (BOM), executing and documenting experimental studies according to local Standard Operating Procedures (SOPs) or established practices, reviewing and reporting data, and contributing to technical reports
Reviews laboratory worksheets and batch records
Understands and applies principles of biosafety to maintain a safe workplace for self and others
Possesses thorough knowledge of the science of cell culture, including growth and characterization of primary cells, cell strains, and immortalized cell lines. Experience with media development is preferred
Applies understanding of regulatory expectations to process development strategies
Experience with authoring technical transfer protocols for cell banking and cell/gene therapy products
Ability to work independently, apply judgement in real-time, and deal with problems of a difficult nature
Manages timelines and milestones in collaboration with clients and external partners

Senior Scientist, Process Development Resume Examples & Samples

Responsible for successful process development and technology transfer of Cell Therapy products, with a focus on gene therapy products and associated vector production
Supports in process characterization of cellular products as needed, either by directly supporting analytical characterization or working with internal QC analytical function
Serves as a technical lead for process transfer of projects to GMP production facilities. Also responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies, where appropriate
Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. Justifies development strategies and experiment designs
Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups. Interacts externally with clients, material/equipment vendors and commercial partners
Reviews worksheets and batch records
Contributes to operations of the process development lab, including training of new employees
Experience in upstream, downstream or formulation process development is required. Familiarity with cell and gene therapy products is preferred, but experience with protein purification/formulation will also be considered
Experience with procedures for the isolation, transduction/activation, expansion and cryopreservation of gene modified patient derived cells. Familiarity with handling of apheresis materials and / or whole blood and related cell processing equipment is preferred
Possesses knowledge of viral vector production at small and/or large scale. Experience with purification of viral vectors is strongly preferred, including chromatography, centrifugation, filtration and TFF. Experience with wave or stirred tank bioreactors is a plus
Ability to perform complex mathematic and statistical calculations and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data
Works in laboratory and production environments with potential exposure to occupational hazards including chemical cleaners, biohazardous materials, noise, mechanical and heat/cold energy. Must be able to wear all required Personal Protective Equipment (PPE). Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program

Scientist, Bioprocess R&d-process Development Resume Examples & Samples

Lead technical initiatives, conduct and oversee studies using cutting edge analytics (LC-MS, GC-MS, ICP-MS, UHPLC, Raman, and similar quantitative methods). This includes performing extractable studies of single-use films and components
Serve as in-house technical expert in the field of applied sciences. Providing technical leadership in the areas of biocompatible materials, process characterization, and biotheraputic stability under various process or storage conditions
Provide expert vision and strategy for aligning to industry standards and protocols related to discovery, manufacture, formulation, efficacy, storage, handling and safety pharmaceuticals and vaccines (BPOG, BPSA, ASME-BE, ASTM, ISO, ISTA, USP, WHO, ICH, FDA, EMA, GMP, ect)
Perform extractable studies of single-use films and components
Independently design robust experimental plans, conduct and oversee studies, and analyze and report study results and recommendations both verbally and in written formats
Perform or support analysis and modeling of components and/or systems (i.e. heat and mass transfer, CFD, surface chemistry, biological networks etc.)
Supports technology transfer into development
Lead in process feasibility, characterization, automation, and validation studies as needed
Document experimental results/concepts to support patent and intellectual property portfolio
Compile findings into documents ready for publication in academic or trade journals
Interact with customer base on new product and process concepts including alpha and beta testing
Present at technical conferences and represent the company as a thought leader in industry
Travel as required to perform job functions.
Bachelor's of Science Degree in related field – chemistry, physics, material science, biotechnology or chemical engineering
Bachelor’s degree, with 5 years of experience, or Advanced degree with 3 years of experience
Knowledge of bioprocessing operations (suspension cell culture, adherent cell culture, harvest & recovery) and cGMP/GLP (Current Good Manufacturing/Lab Practices) type environments
Strong knowledge of cell biology and/or biochemistry, especially with respect to interaction with biopharmaceutical processes and process equipment
Experience in the medical device or biopharmaceutical industries
Experience and knowledge of analytical instrumentation (eg – HPLC, GC-MS, LC/MS)
Software proficiency: MS office programs, Xcalibur, Chromeleon, DeltaV, SAS/JMP, DoE, Matlab/simulink, Visio
Proficient in scientific method/analysis and applied mathematics/statistics
Ability to deconstruct technology concepts into core principles and determine feasibility for product development
Team oriented with excellent written and oral communication skills
Project management skills, time management discipline, Gantt charting
Experience directing technicians for maximum resource utilization
College engineering or science degree in applicable technical field
Advanced degree or BS w/ +5 years of relevant experience
Laboratory research or process development experience
Ability to learn quickly, work independently and in groups
Position may include travel up to 15%

Scientist, Gum& Candy Process Development Resume Examples & Samples

Provide RD&Q timeline, prepare risk assessment based on active cooperation with the factories
Support continuous improvement for all process development aspects
BS, MS or PhD in Food Technology, Chemistry, Micro, Chemical/Food Engineering or related discipline (desirable)
Fluent English language skills

Senior Scientist, RD&Q Process Development Resume Examples & Samples

Develop clear Critical To Process (CTP) and Critical to Quality (CTQ) specifications for individual product families, and ensure that Product and Pack Appearance Standards (PAPAS) are fully aligned with other functions
Actively lead the execution stages of various project types (Growth, Margin Management, Brand Maintenance & Quality Improvement). Be able to lead and fully commercialize new or existing products and recipes on manufacturing lines, following C-Q-V procedures
Initiate discussions with other functions to ensure alignment not only within R&D but with others when planning and executing SCR projects
Able to clearly summarise and articulate key technical points in communicating cross-functionally, and able to influence and convince stakeholders of a particular course of action where necessary
Produce prototypes in the laboratory and run trials on industrial manufacturing lines. Generate appropriate trial reports and feedback results to stakeholders
Follow Mondelēz International’s Policies (Code of Conduct, PQS, GMP, etc.) Employee Safety and Food Safety are paramount (no exceptions, no risk taking) – role model behaviour is expected
Provide updates of SCR projects to other teams within R&D and other functions
Facilitate join up between GCT and plants affected by SCR projects to help aid knowledge transfer
Develop others not only in project specific areas such as ways of working, but in product knowledge and work skills. For example, taking opportunities to train others as part of technical academies
Carry out specific assignments and ad-hoc tasks/projects as required. (may include trouble-shooting, supplier visits and analytical tasks)
Strong background in Food Science/Technology, or Chemical/Mechanical Engineering
Experience of working in multi-disciplinary/multi-cultural teams
Knowledge of Continuous Improvement (CI) methodology such as L-6-S
Extensive experience in a manufacturing environment
Technical understanding of products and processes
Good knowledge of key Mondelez business systems including I-2-M, IIM, Meridian, PPMS, QMS, etc
Product specifications
Process specifications

Scientist Upstream Process Development Resume Examples & Samples

Upstream process design, optimization, and tech transfer
M.S. or Ph.D.: Chemical/Biochemical Engineering, Biochemistry, Biophysics or equivalent with a minimum of 5+ years of industry and/or academic experience
In depth understanding and hands on experience in upstream process development, bioreactor operation and scale-up/ down, media development
Practical experience with downstream processing and analytical techniques relating to glycoprotein attributes
Knowledge of cell culture process characterization

Senior Scientist, Process Development Resume Examples & Samples

Develop recovery and purification process that utilizes clarification, chromatography, and membrane filtration technologies for recombinant proteins
Design and execute innovative process development and characterization activities, impurity and viral clearance studies
Is responsible for technology transfer to manufacturing facilities, and serve as contact and consultant for troubleshooting and investigation activities
Serve as a technical resource and leader for project teams, and provide tactical perspectives as appropriate
Identify and solve technical problems independently, conceive and implement innovative process research ideas, evaluate and integrate state-of-the-art technology to improve process, and demonstrate a high level of scientific initiative
Act as subject matter expert, support and contribute to regulatory filings
Author technical report, and ensure consistency and quality of technical reports from employees supervised
Influence areas in own discipline within department
Provide project update, analysis and advice to cross-functional team and senior management
Present original work internally across departments and divisions, and at external conferences
May supervise 1-2 direct reports
PhD degree in chemical engineering or biochemical engineering or related disciplines
7+ years of experiences in protein purification process development and manufacturing support
Sound scientific understanding of current protein separation technologies and ability to explore and develop new approaches to further advance innovative purification technologies desirable
Basic knowledge in related functional areas, such as cell culture, protein chemistry and analytics, formulation, CMC and regulatory, preferred
Well-recognized in the scientific community through a sustained record of peer-reviewed publications and patents preferred
Candidate must be a goal oriented team player with excellent verbal and written communication skills

Scientist, Process Development Resume Examples & Samples

Developing scalable, economical, and robust purification process for recovering the target protein from bioreactor harvest using chromatography, filtration, and other separation techniques
Assist process tech transfer to GMP manufacturing, on-floor production support and troubleshooting production issues
Executing viral clearance, process characterization, and continuous process improvement studies, performing basic data acquisition and analysis, documenting lab notebooks, authoring technical memos and reports
Bachelor's or Master's degree in chemical or biochemical engineering, biochemistry and biology, with 2-5 years of work experience is required with basic knowledge of protein purification and standard analytical techniques
The candidate must have a strong desire to work at the laboratory bench; must possess good written, oral and collaborative skills in order to effectively communicate experimental procedures and results

Scientist Process Development Gum & Candy Resume Examples & Samples

Master Degree in Chemical engineering, Food Technology or Food Engineering
Internship or up to 3 years in Product/Process Development within Food industry. Experience in confectionery is a strong advantage
General knowledge of food manufacturing technologies, ingredients and ability to operate the equipment
Experience with RD&Q systems such as Specification Management System, Project Management System, Quality Management, Productivity Tracking
Ability to work across boundaries / functions and to collaborate with others to deliver results
Ability to apply technical know-how to understand and develop product and processes
Knowledge in Food safety and Lean Six Sigma
Passion about science, creativity, innovation and continuous improvement mind set
Fluency in English required, other language skills (Polish) are beneficial