Associate Principal Scientist, Upstream Process Development

Job Description

The Biologics Process Research & Development organization within our Research & Development Division is responsible for developing the drug substance manufacturing processes for our Company’s biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical, and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We also handle late‑stage process development and process characterization to prepare for commercial manufacturing, collaborating with the Company Manufacturing Division to commercialize and launch new products.

The Associate Principal Scientist will support the Upstream Process Development team by designing, developing, and optimizing cell culture processes, and managing the transfer of processes to clinical and commercial manufacturing sites. The position requires effective organizational and multi‑tasking skills, strong scientific leadership in upstream process development, advanced written and oral communication abilities, cross‑functional collaboration, external scientific presence, mentoring of junior staff, and a commitment to process innovation and cost‑efficiency.

• Lead or participate in upstream process development of first‑in‑human and commercial processes, creating high‑yield, robust, and scalable cell culture protocols.
• Drive process development, characterization, and regulatory filing activities to enable successful process qualification and regulatory submissions.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to create integrated clinical and commercial solutions that meet quality‑by‑design goals.
• Advance the upstream platform through creative process‑improvement initiatives that increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to adopt new technologies and drive innovation.
• Keep up with external literature, present and publish findings, and pursue patent strategies.

• Ph.D. with 4+ years of experience or Master’s with 8+ 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 recombinant protein production.
• Knowledge of CHO cell biology, metabolism, media, and engineering principles for large‑scale production.
• Proficiency in statistical methods (design of experiments, multivariate data analysis) and related tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors, from bench‑scale to pilot‑scale, and principles of scale‑up.
• Demonstrated accomplishments in upstream process and technology development, including a strong publication and presentation record.
• Ability to plan, execute, analyze, and document all stages of cell culture process development.
• Excellent verbal, written, and interpersonal communication skills.
• Experience working in cross‑functional, matrixed teams and collaborating with internal and external partners, including vendors.
• Creative problem‑solving and initiative‑driven mindset.
• Productivity and efficiency in laboratory work.
• Ability to deliver complex objectives under aggressive timelines.

• Experience with cell culture media development.
• Experience with high‑throughput microbioreactor systems and advanced in‑situ analytics.
• Experience with intensified inoculum/fed‑batch and perfusion process development.
• Background in data science approaches related to cell culture and predictive modeling (e.g., metabolic flux analysis, omics, machine learning, computational fluid dynamics) and integration of PAT efforts.
• Experience with late‑stage commercial process development, technology transfer, scale‑down model qualification, and process characterization.
• Knowledge of biologics CMC development cycles, scale‑up/down, and GMP tech transfer.

Salary range: $ - $. The range represents the lowest to highest salary we believe we would offer for this role at the…