Associate Principal Scientist, Upstream Development

Biologics Process Research & Development Organization

Within our company’s Research Laboratories, the Biologics Process Research & Development organization is responsible for developing the drug substance manufacturing processes for our biologics pipeline. We work closely with colleagues in Discovery, Pre‑clinical, and Early Development to rapidly develop manufacturing processes for biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and implementation of new manufacturing technologies, working with the Manufacturing Division to commercialize and launch new products.

We are seeking a highly motivated and energetic individual to join our Biologics Process Development Department as an Associate Principal Scientist. The successful candidate will work closely with a highly motivated team of scientists and engineers in the Upstream Process Development area and contribute to CMC development of our pipeline. They will play an active role in designing, developing, and optimizing cell culture processes and transferring processes to clinical and commercial manufacturing sites, and participate in technology development initiatives for assets in early and late‑stage clinical development.

• Lead or participate in upstream process development of first‑in‑human and commercial processes, efficiently developing high‑yield, robust, and scalable cell culture processes.
• Oversee process development, process characterization, and regulatory filing activities to ensure a clear path to successful PPQs and BLAs.
• Partner with colleagues in Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to develop integrated clinical and commercial process and manufacturing solutions that achieve Quality by Design targets with robust control strategies.
• Advance the upstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.
• Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.
• Keep up to date with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.

• Ph.D. with 4+ years of experience OR Master’s with 8+ years of experience OR bachelor’s with 12 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 to produce recombinant proteins.
• 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 (Design of Experiments, multivariate data analysis) and tools (SIMCA, JMP, etc.).
• Understanding of cell culture bioreactors including microbioreactors, bench‑scale and pilot‑scale bioreactors, and bioreactor scale‑up principles from laboratory to large scale.
• Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation record.
• Ability to plan, execute, analyze, and document all stages of cell culture process development and communicate complex data in a highly organized manner.
• Excellent verbal, written, and interpersonal communication skills and ability to work effectively in a cross‑functional, matrixed team environment.
• Demonstrated initiative, creativity, and innovation in problem‑solving, productivity, and efficiency in the laboratory.
• 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 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…