Associate Principal Scientist, Upstream Process Development
About The Position
The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline. It works with Discovery, Pre-clinical and Early Development to develop manufacturing processes and supply clinical trials, and supports late-stage process development, process characterization, commercialization, and product launches. The Associate Principal Scientist will work with Scientists and Engineers in Upstream Process Development and contribute to CMC development of the company’s pipeline. The role includes designing, developing, and optimizing cell culture processes and transferring processes to clinical and commercial manufacturing sites. The successful candidate is expected to demonstrate scientific leadership, strong organization and multitasking, excellent communication, cross-functional collaboration, external scientific engagement, and an interest in mentoring junior staff.
Requirements
- Ph.D. with 4 or more years of experience, or a Master’s degree with 8 or more years of experience, in chemical engineering, bioengineering, biological engineering, or a related field.
- Hands-on experience with mammalian cell culture and fed-batch processes for producing recombinant proteins.
- Working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale recombinant protein production.
- Working knowledge of statistical methods, including design of experiments and multivariate data analysis, and tools such as SIMCA and JMP.
- Understanding of cell culture bioreactors, including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up principles from laboratory to large scale.
- Track record of accomplishments in upstream process and technology development, with strong scientific publication and presentation experience.
- Ability to direct planning, execution, analysis, and documentation across all stages of cell culture process development.
- Excellent verbal and written communication and interpersonal skills.
- Ability to work effectively in cross-functional, matrixed teams and collaborate with internal and external partners, including vendors.
- Demonstrated initiative, creativity, and innovation in problem solving.
- Productivity and efficiency in the laboratory.
- Ability to deliver complex objectives under aggressive timelines.
- Proficiency in bioreactor simulation and modeling.
Nice To Haves
- Experience with cell culture media development.
- Experience with high-throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
- Experience with state-of-the-art cell culture processes, including intensified inoculum/fed-batch and perfusion process development.
- Background in data science approaches related to cell culture and predictive modeling, such as metabolic flux analysis, omics, and machine learning; computational fluid dynamics; and integrating PAT efforts.
- Experience with late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
- Knowledge of the biologics CMC development cycle, scale-up/down, and technology transfer to a GMP manufacturing site.
Responsibilities
- Participate in and/or lead upstream process development for first-in-human and commercial processes, developing high-yield, robust, and scalable cell culture processes.
- Conduct process development, process characterization, and regulatory filing activities to support PPQs and BLAs for the company’s pipeline.
- Partner with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing colleagues to develop integrated clinical and commercial process and manufacturing solutions that meet quality-by-design targets with robust control strategies.
- Advance upstream platform processes through process improvement initiatives that increase operational efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to develop, innovate, and adopt new process technologies.
- Keep current with external literature, present and publish externally, and pursue patenting strategies.
- Plan, execute, analyze, and document all stages of cell culture process development.
- Plan, execute, analyze, and communicate complex and critical data in an organized manner.
- Mentor junior staff.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
- Domestic relocation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
