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 for diverse biotherapeutics and manufacture material for clinical trials. The organization also conducts late-stage process development and process characterization in preparation for commercial manufacturing, and works with the Manufacturing Division to commercialize and launch new products. The Associate Principal Scientist will work with Scientists and Engineers in Upstream Process Development and contribute to CMC development for the company's pipeline. The role involves designing, developing, and optimizing cell culture processes and transferring processes to clinical and commercial manufacturing sites. The successful candidate is expected to demonstrate organizational and multitasking ability, scientific leadership, strong written and oral communication, cross-functional collaboration, external scientific engagement, and an interest and ability in mentoring junior staff.
Requirements
- Ph.D. with 4 or more years of experience, or Master's degree with 8 or more years of experience, in chemical engineering, bioengineering, biological engineering, or a related field.
- Technical background and hands-on experience with mammalian cell culture and fed-batch processes for recombinant protein production.
- Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale recombinant protein production systems.
- 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 systems, and bioreactor scale-up principles from laboratory to large scale.
- Track record of accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
- 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 laboratory work.
- 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 experience 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 GMP manufacturing sites.
Responsibilities
- Participate in and/or lead upstream process development for first-in-human and commercial processes, efficiently developing high-yield, robust, and scalable cell culture processes.
- Lead process development, process characterization, and regulatory filing activities to support successful 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 and use 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 drive process development, innovation, and adoption of new 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.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and their families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligibility for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
