Principal Scientist, Upstream Process Development

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 are also responsible for late-stage process development and process characterization to prepare for commercial manufacturing.

We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

• The successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites.
• Develop strategies for process and pipeline-facing innovation.
• Leading biologic upstream process development for first-in-human and commercial processes by 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 our company pipeline.
• Advance upstream platform process technical strategy and champion creative process improvement initiatives.
• Initiate new collaborations to assess new technologies and industry strategies with relevance to our 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.
• Keep current with the external patent and literature environment; actively present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.

Ph.D. with 6+ years of industry experience or Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.

• Proven record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.
• Experience in CHO fed-batch cell culture and a working understanding of downstream & analytics.
• Understanding and hands-on experience on cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up/tech transfer activities.
• Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.
• Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.
• Knowledge of biologics CMC development cycle.
• Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop staff to maximize utilization of talent and actively guides career development; builds strong and collaborative teams.

• Experience with state-of-the-art cell culture processes including intensified inoculum and perfusion process development.
• Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
• Expertise in media development, media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling e.g., metabolic flux analysis (MFA), omics, machine learning; experience integrating PAT efforts and computational fluid dynamics (CFD).
• 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 Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Strategic Thinking, Technology Transfer

Current Employees apply HERE;
Current Contingent Workers apply HERE

US And Puerto Rico Residents Only

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