Principal Scientist, Upstream Process Development

Job Overview

The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing drug substance manufacturing processes for our company's biologics pipeline. We rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material for clinical trials. We also perform late‑stage process development and characterization to prepare for commercial manufacturing, and partner with the Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and experienced Principal Scientist to lead cross‑functional teams, develop CMC packages for pipeline assets, and collaborate with Bioprocess Development colleagues on next‑generation processing strategies for assets in early‑ and late‑stage development.

• Lead biologic upstream process development for first‑in‑human and commercial processes, efficiently developing high‑yield, robust, and scalable cell culture processes.
• Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company pipeline.
• Advance upstream platform process technical strategy and champion creative process improvement initiatives.
• Initiate new collaborations to assess new technologies and industry strategies relevant to the company.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies with broad impact to projects or platform.
• Stay current with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.
• Contribute to CMC development of the company pipeline and play an active role in the development of cell culture processes and transfer to clinical and commercial manufacturing sites.

Minimum education required: Ph.D. with 6+ years of industry experience, or M.S. with 8+ years of industry experience in Chemical Engineering, Bioengineering, Biochemistry, or a related field.

• Proven record of accomplishments in upstream process and technology development with a strong publication and presentation track record.
• Experience in CHO fed‑batch cell culture and a working understanding of downstream & analytics.
• Hands‑on experience with cell culture bioreactors, including microbioreactors, bench‑scale and pilot‑scale bioreactors, and scale‑up/tech‑transfer activities.
• 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 environment and collaborate with internal and external partners, including vendors.
• Knowledge of the biologics CMC development cycle.
• Experience with late‑stage commercial process development, technology transfer, scale‑down qualification, and process characterization.
• Demonstrated initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop staff, maximize utilization of talent, and guide career development while building strong, collaborative teams.

• Experience with state‑of‑the‑art cell culture processes, including intensified inoculum and perfusion development.
• Experience with high‑throughput microbioreactor systems and advanced in‑situ analytics for process monitoring and control.
• Expertise in media development and media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling (e.g., metabolic flux analysis, omics, machine learning), integration of PAT efforts, and computational fluid dynamics.
• Experience leading cross‑functional, program development teams.

• Adaptability
• Cell Culture Process Development
• Cell Line Development
• Combination Products
• Data Analysis
• Finite Element Analysis (FEA)
• Innovative Thinking
• Leadership/Mentoring
• Pharmaceutical Process Development
• Professional…