Principal Scientist, Upstream Development
About The Position
The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company's biologics pipeline, supports clinical-trial material supply, develops commercial processes, and implements new manufacturing technologies. It works with Discovery, Pre-clinical and Early Development, as well as manufacturing partners, to develop and commercialize biologics. The Principal Scientist will join the Upstream Development Department and work with its scientists to develop and refine technical strategy for next-generation processing for assets in early- and late-stage clinical development. The role contributes to CMC development by developing cell culture processes and transferring them to clinical and commercial manufacturing sites, while creating strategies for process and pipeline-facing innovation. The successful candidate will provide scientific leadership, collaborate across functions and with external partners, lead projects, mentor junior scientists, and use data science and digital tools to solve complex problems.
Requirements
- Ph.D. with 8 or more years of industry experience, master's degree with 10 or more years of industry experience, or bachelor's degree with 14 or more years of industry experience in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
- Record of accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
- Experience in CHO fed-batch cell culture and working understanding of downstream processing and analytics.
- Hands-on experience with cell culture bioreactors, including microbioreactors, bench-scale and pilot-scale systems, and scale-up and technology transfer activities.
- Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics, and computational fluid dynamics.
- Ability to plan, execute, analyze, and document all stages of cell culture process development.
- Ability to work in a matrixed team and collaborate with internal and external partners, including vendors.
- Knowledge of the biologics CMC development cycle.
- Demonstrated initiative, creativity, and innovation in problem-solving.
- Demonstrated ability to develop staff, guide career development, and build strong collaborative teams.
Nice To Haves
- Experience with state-of-the-art cell culture processes, including intensified inoculum and perfusion process development.
- Experience with early- and late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
- Experience with high-throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
- Expertise in media development and media or solution chemistry.
- Data science experience related to cell culture and predictive modeling, such as metabolic flux analysis, omics, or machine learning; experience integrating PAT efforts and computational fluid dynamics.
- Experience leading cross-functional program development teams.
Responsibilities
- Lead biologic upstream process development for first-in-human and commercial processes, developing high-yield, robust, and scalable cell culture processes.
- Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to support PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process improvement initiatives.
- Initiate collaborations to assess new technologies and industry strategies relevant to the company.
- Collaborate with academia, industry partners, and vendors to develop, innovate, and adopt process technologies with broad project or platform impact.
- Stay current with external patent and literature developments; present and publish externally and pursue patenting strategies.
- Supervise, coach, and educate junior scientists.
- Direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
- Develop staff, maximize use of talent, guide career development, and build collaborative teams.
Benefits
- Medical, dental, and 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 an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
