Process Development Scientist Resume
Objective : As a Process Development Scientist, responsible for developing methods and transferring of known processes from clients for recombinant proteins or small molecule purification using chromatography techniques such as affinity, ion exchange, and size exclusion chromatography.
Skills : Technical Expertise, Experimental Design.
Description :
- Purified proteins and other biomolecules through process development chromatography.
- Operated and maintained systems for protein purification, ensuring optimal performance and efficiency.
- Designed experimental approaches, process characterization, scale-up, and technology transfer to GMP manufacturing.
- Carried out literature searches as appropriate to currently known methods, designed new approaches as required, and prepared research plans.
- Communicated to stakeholders throughout projects, including client presentations and written reports of experimental results.
- Managed Tech transfer from laboratory scale to production scale.
- Interpreted associated analytical results and knowledge and used current techniques to characterize the quality of the resulting product.
Experience
0-2 Years
Level
Entry Level
Education
Bachelor's Degree in Chemical Engineering
Senior Process Development Scientist Resume
Summary : As a Process Development Scientist, responsible for the day-to-day management of project team members and research assignments, including designing and interpreting of experimentation.
Skills : Scale-Up and Scale-Down.
Description :
- Assisted the departmental manager, ensuring the workplace was clean and equipment was well maintained.
- Trained and supervised research assistants or summer students if needed.
- Kept accurate records and supported the development of technical documentation.
- Developed cross-functional understanding and awareness through exposure to diverse projects, products, and teams.
- Operated current laboratory instrumentation and adhered to laboratory safety, SOPs, and GMP/GLP regulations.
- Recommended minor modifications to existing systems, processes, techniques, or programs for improvement.
- Monitored bioprocess steps in the production of pilot-scale biopharmaceutical products.
Experience
10+ Years
Level
Senior
Education
Bachelor's degree in Biochemistry
Senior Process Development Scientist Resume
Summary : As a Senior Process Development Scientist, responsible for analyzing experimental data using statistical software and interpreted results to draw meaningful conclusions.
Skills : Process development and optimization.
Description :
- Led the development and optimization of manufacturing processes for biologic drug substances, focusing on upstream and downstream operations.
- Designed and executed experiments to evaluate process parameters, identify critical process parameters (CPPs), and establish process control strategies.
- Employed statistical analysis tools such as Design of Experiments (DOE) to optimize process parameters and improve process robustness.
- Collaborated cross-functionally with R&D, manufacturing, engineering, and quality assurance teams to ensure seamless technology transfer and scale-up of processes.
- Developed and implemented process characterization studies to support process validation activities and regulatory submissions.
- Authored and reviewed technical documents, including process development reports, batch records, and regulatory filings.
- Drove continuous improvement initiatives to enhance process efficiency, product quality, and compliance with regulatory requirements.
Experience
10+ Years
Level
Senior
Education
Bachelor's degree in Biochemistry
Process Development Scientist Resume
Summary : As a Process Development Scientist, prepares and reviews technical documents including research reports, process development reports, and documentation for the manufacturing of chemical substances.
Skills : Quality and Compliance, Problem-Solving.
Description :
- Monitored the work according to required SOPs for engineering runs (documentation, developing sample plans, labeling, equipment use, and cleaning).
- Took ownership over the process transfer, facility fit experiments, and scale-up parameters.
- Prepared and presented process data internally and externally.
- Established a thorough understanding of lab and available process information to enable the writing and/or review of pilot-scale Batch Production Records.
- Took ownership for the pilot-scale BPRs by ensuring the data collected supported the process transfer protocol.
- Supported the development of BPRs for new processes and changes to existing processes.
- Created the initial statistical process control file.
Experience
7-10 Years
Level
Management
Education
Bachelor of Science in Chemistry
Associate Process Development Scientist Resume
Summary : As a Process Development Scientist, maintains a portfolio of research projects driven by fundamental research, new product innovation, product contribution and infrastructure goals, while providing individuals and teams the freedom to emphasize specific types of work.
Skills : Statistical Analysis, Project Management.
Description :
- Wrote technology transfer risk assessments, tech transfer protocols, and summary reports for internal and external use.
- Analyzed and reviewed process data, reports for scale-up, process control, annual reviews, and investigations.
- Performed field tests in the pilot or production environment as required to minimize process scale-up risk.
- Interacted with process readiness teams for new processes as well as process modifications.
- Maintained proficiency in the operation of all relevant pieces of process equipment.
- Created, collaborated, and trained Operations Staff on equipment and process-specific training.
- Responsible for developing chemical processes for the manufacturing of drug substances.
Experience
7-10 Years
Level
Management
Education
PhD in Organic Chemistry
Junior Process Development Scientist Resume
Objective : As a Process Development Scientist, deploys promising ideas quickly and broadly, managing deadlines and deliverables while applying the latest theories to develop new and improved products, processes, or technologies.
Skills : Communication, Safety Awareness, Continuous Improvement.
Description :
- Demonstrated technical knowledge, scientific creativity, and collaboration skills in the development and execution of research for the preparation of novel chemical substances.
- Planned, executed, and analyzed laboratory experimentation to advance the knowledge of production and quality attributes of drug substances.
- Proposed alternative chemistry, including new route selection and step optimization.
- Provided regular updates to supervision and proposed future research directions.
- Collaborated across functional areas including analytical chemistry, quality assurance, and manufacturing to accomplish project goals.
- Provided technical support for manufacturing processes performed under cGMP in laboratory manufacturing and large-scale manufacturing operations.
- Designed and executed experiments to develop a robust process with a focus on the best procedures for stem cell banking, cell thawing, and cell handling.
Experience
0-2 Years
Level
Junior
Education
Master’s degree in Pharmaceutics
Assistant Process Development Scientist Resume
Objective : As a Process Development Scientist, designs experiments that build fundamental understanding of new chemistries materials of compatibility, vapor pressure measurement, boiling points, melting points, thermal stability.
Skills : Commercial acumen, Presentation skills.
Description :
- Conducted stem cell expansion and directed differentiation process characterization for evaluating/verifying the process.
- Evaluated and implemented novel technologies, equipment platforms, and high-throughput approaches for improving cell banking and cell culture expansion processes.
- Collaborated with cross-functional teams, aligned on project goals, shared results, and fostered a collaborative working environment.
- Developed internal documentation, protocols, and reports to support regulatory filings, and the transfer of processes to the manufacturing group.
- Drove project delivery, ensuring the successful execution of process development initiatives and meeting project milestones.
- Supported manufacturing operations/investigations from a product impact perspective.
- Authored and reviewed technical protocols, reports, and regulatory sections in support of submissions.
Experience
2-5 Years
Level
Executive
Education
Bachelor of Science in Chemistry
Process Development Scientist Resume
Summary : As a Process Development Scientist, participates in the planning, design, completion, and documentation of studies related to drug product manufacturing and process development in support of the commercialization and life cycle management of biologic therapeutics.
Skills : Project management skills, Attention to detail.
Description :
- Evaluated process performance through statistical methodology/trending review and reported on associated feedback.
- Actively utilized IS systems to improve drug product processing through faster data availability, using historical information, analyzing large datasets, and statistical analysis.
- Built visualizations to enable business application of data analysis.
- Explored and evaluated new digital tools and techniques to improve the team’s developmental and operational capabilities.
- Participated in global cross-functional teams working efficiently in a highly matrixed environment to progress product development.
- Supported standardization and improvements of departmental practices by adding to guideline documents.
- Delivered progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.
Experience
7-10 Years
Level
Consultant
Education
PhD in Organic Chemistry
Process Development Scientist Resume
Summary : As a Process Development Scientist, provides support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations, process changes/improvements, and regulatory inspections.
Skills : Technical skills, Analytical mind.
Description :
- Led the process development, characterization, and technology transfer for recombinant subunit and/or vaccine products.
- Contributed to the development of new principles, concepts, and methods to enable process development, scale-up of processes to pilot scale, and technology transfer to manufacturing scale.
- Designed, executed, and analyzed process development experiments to maximize understanding of recombinant subunit and/or vaccine production processes.
- Developed robust and scalable manufacturing processes while minimizing time to file and launch.
- Represented functional area in cross-functional and strategic teams engaged in novel vaccine development.
- Supported strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.
- Designed and executed robust and scalable cell culture processes in ambr250, 2L, 50L, 200L 500L single-use bioreactors.
Experience
10+ Years
Level
Senior
Education
PhD in Organic Chemistry
Process Development Scientist Resume
Summary : As a Process Development Scientist, led and managed process development studies using sound scientific and engineering principles to develop and improve end-to-end operations used for production of autologous T-cell therapies.
Skills : Cross-functional team skills, Production work skills.
Description :
- Designed scalable inoculum expansion and master cell bank generation processes.
- Designed and executed small-scale and pilot-scale depth filtration and centrifugation primary recovery processes.
- Provided person-in-plant support at the GMP manufacturing facility.
- Authored and reviewed technical reports, GMP campaign summary reports, and relevant sections in regulatory filings.
- Actively sought out opportunities to optimize our platform or enhance our understanding of cell culture processes.
- Contributed to publishing or presenting scientific findings in in-house or external conferences.
- Supported cGMP manufacturing and technology transfer to internal manufacturing facilities and external contract manufacturers.
Experience
7-10 Years
Level
Management
Education
Master’s degree in Pharmaceutics
