Sr. Scientist, Preclinical Dev.

MSD • Upper Gwynedd Township, PA

3d • $117,000 - $184,200 • Hybrid

About The Position

Applications are sought for an opportunity in the Vaccine Process Development (VPD) department, which is part of our Company's Research Labs division. The individual will support our Company's discovery & development efforts for Vaccine programs at West Point, PA. Role Summary: Vaccines and Advanced Biotechnologies Process R&D (VaxPRD) is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DP process development and clinical manufacturing for our company's pipeline. Our vaccines upstream process development team develops safe, scalable, robust, cost-effective upstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities. The successful candidate is expected to work with other upstream scientists and engineers, typically focusing on one to two vaccine programs at a time, while also supporting the overall program management and governance activities across larger multi-functional and cross-divisional teams. The candidate must have the ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Drive collaborative engagement with partner organizations such as purification, analytical, PAT, manufacturing, and regulatory. The candidate must have the ability to learn new techniques, to balance multiple projects, to keep accurate records, to follow instructions, and to comply with company policies. The successful candidate will possess proven ability to work in a hands-on laboratory setting and excellent organization, interpersonal, verbal and written communication skills. Independently design, execute, and analyze process development experiments to maximize understanding of cell culture and fermentation processes to enable robust vaccine manufacturing. Conduct laboratory bench work to execute, optimize, and troubleshoot cell culture and fermentation processes (e.g., shake flasks, bench scale and pilot scale bioreactors). Apply data analysis and basic data science/modeling approaches (e.g., statistics, design of experiments) to design experiments, interpret datasets, and support process understanding and optimization. Contribute to the development and scale‑up of upstream processes from lab scale to pilot scale and support technology transfer to manufacturing scale. Perform upstream unit operations as needed, including lab scale cell culture, fermentation, centrifugation, filtration, and in-process assays. Prepare clear technical reports and presentations to summarize and communicate experimental results and recommendations in a collaborative team environment, including contributing to regulatory documentation and filings. Supervise/mentor and provide technical guidance to contract staff or new hires in laboratory techniques and best practices, as appropriate. Serve as workstream lead focused upon development of process operations or advancing upstream technologies and/or control strategies. Keep accurate, detailed laboratory records; comply with all required training and maintain a strong focus on laboratory/facility safety for self and team members. Contribute 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 Develop and apply advanced process characterization tools/analytics (e.g., PAT, Systems Biology) toward developing, improving, and understanding upstream bioprocesses. Independently design, execute, and analyze process development experiments to maximize understanding of cell culture and fermentation processes to make vaccine products. Analyze, summarize, and present experimental results in a collaborative team environment. Interface with multidisciplinary groups and coordinate multiple program activities with Process R&D, Analytical R&D, Vaccine Basic Research, Commercialization, and various functional groups.

Requirements

• Must have a BS or MS or PhD in relevant field: Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering Science and Technology: Cell Biology, Biological Sciences, Biotechnology, or Biochemistry
• For BS, at least six (6) years of experience in bioprocess/biotechnology-related position (vaccines and/or therapeutic proteins)
• For MS, at least five (5) years of experience in bioprocess/biotechnology-related position (vaccines and/or therapeutic proteins)
• Must have strong scientific understanding of fermentation and/or cell culture processes.
• Prior experience in optimizing recombinant protein expression (quality and quantity of product).
• Prior experience with fermentation bioprocesses (E. coli, Yeast) or mammalian systems (CHO, HEK293, etc.)
• Sound understanding of process scale-up principles across scales from high-throughput, lab, pilot, and commercial.
• Must have experience with hands-on bioprocess development preferably across multiple organisms/expression systems.
• Excellent scientific understanding of cell biology for vaccine production including cell metabolism and molecular biology
• Demonstrated proficiency in bench scale bioreactor, shake flask, or other cell propagation systems for the optimization of cell culture or fermentation processes
• Position requires employee to be willing to work with infectious agents and/or pathogens.
• Position requires occasional travel and off-hour/weekend work.
• Adaptability
• Biodesign
• Biomedical Engineering
• Biomedical Sciences
• Bioprocessing
• Cell Cultures
• Chemical Engineering
• Cross-Functional Teamwork
• Data Analysis
• Drug Delivery Technology
• Flow Cytometry
• Following Instructions
• High-Throughput Screening
• Innovative Thinking
• Interpersonal Relationships
• Mammalian Cell Culture
• Microbiology
• Molecular Biology Techniques
• Multi-Color Flow Cytometry
• Preformulation
• Process Optimization
• Production Process Development
• Project Management

Nice To Haves

• Prior experience with the application of PAT for monitoring upstream bioprocesses
• Prior experience with the application systems biology approaches (e.g., “-omics”) to increase process understanding and/or solve upstream bioprocess challenges
• Ability to interface with discovery colleagues to influence pre-clinical development (expression system selection, protein engineering, etc.).
• Experience with data science and modeling tools (e.g., statistics, design of experiments, and/or coding/scripting such as Python or similar tools for data analysis and modeling).
• Demonstrated experience/training with project management, enabling process development efforts.

Responsibilities

• Independently design, execute, and analyze process development experiments to maximize understanding of cell culture and fermentation processes to enable robust vaccine manufacturing.
• Conduct laboratory bench work to execute, optimize, and troubleshoot cell culture and fermentation processes (e.g., shake flasks, bench scale and pilot scale bioreactors).
• Apply data analysis and basic data science/modeling approaches (e.g., statistics, design of experiments) to design experiments, interpret datasets, and support process understanding and optimization.
• Contribute to the development and scale‑up of upstream processes from lab scale to pilot scale and support technology transfer to manufacturing scale.
• Perform upstream unit operations as needed, including lab scale cell culture, fermentation, centrifugation, filtration, and in-process assays.
• Prepare clear technical reports and presentations to summarize and communicate experimental results and recommendations in a collaborative team environment, including contributing to regulatory documentation and filings.
• Supervise/mentor and provide technical guidance to contract staff or new hires in laboratory techniques and best practices, as appropriate.
• Serve as workstream lead focused upon development of process operations or advancing upstream technologies and/or control strategies.
• Keep accurate, detailed laboratory records; comply with all required training and maintain a strong focus on laboratory/facility safety for self and team members.
• Contribute 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
• Develop and apply advanced process characterization tools/analytics (e.g., PAT, Systems Biology) toward developing, improving, and understanding upstream bioprocesses.
• Independently design, execute, and analyze process development experiments to maximize understanding of cell culture and fermentation processes to make vaccine products.
• Analyze, summarize, and present experimental results in a collaborative team environment.
• Interface with multidisciplinary groups and coordinate multiple program activities with Process R&D, Analytical R&D, Vaccine Basic Research, Commercialization, and various functional groups.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior