Upstream Process Development Lead

ROLE SUMMARY

This laboratory-based leadership role will lead upstream process development for both mammalian cell culture and microbial fermentation platforms within Vaccines Early Bioprocess Development (EBPD). The incumbent will provide scientific and people leadership for the design, planning, execution, and interpretation of experiments supporting recombinant protein and vaccine antigen production. The role requires strong expertise in upstream process development, including host and cell-line evaluation, media and feed optimization, bioreactor process development, and integration of product yield and quality considerations.

The successful candidate is expected to bring deep expertise in at least one platform, mammalian cell culture or microbial fermentation, together with demonstrated knowledge of and ability to lead programs across the other platform. Responsibilities include application of high‑throughput and scale-down models, Design of Experiments (DOE), process characterization and modeling, scale‑up, technology transfer, and development of processes suitable for good manufacturing practice (GMP) manufacture.

Experience with automated and conventional bioreactor systems, such as am , stirred‑tank bioreactors, and rocking‑motion bioreactors, is highly valued. The role requires rigorous documentation, clear communication of data and recommendations, effective cross‑functional collaboration, and a proven record of scientific and team leadership.

• Provide scientific and people leadership for the upstream process development workstream spanning mammalian cell culture and microbial fermentation within the Vaccines EBPD Process Development group.
• Lead the design, prioritization, execution, documentation, and communication of complex studies to improve cell growth, recombinant protein expression, product yield, and quality across mammalian and microbial production systems, using DOE and mechanistic modeling approaches where appropriate.
• Direct the evaluation and optimization of production hosts or cell lines, inoculum and seed‑train strategies, culture media and feeds, and bioreactor operating parameters.
• Apply platform‑appropriate strategies to mammalian cell culture and microbial fermentation while identifying opportunities for common workflows, high‑throughput experimentation, automation, digital tools, and continuous improvement.
• Provide scientific judgment and coaching to direct reports and collaborators. Translate experimental results into clear process development decisions, risk assessments, and recommendations.
• Lead upstream scale‑up and technology‑transfer activities through effective cross‑functional interfaces. Author or review development reports, process descriptions, and technology‑transfer documentation.
• Represent the Process Development group on project subteams and collaborate with colleagues across Vaccines EBPD and partner organizations to align plans, timelines, deliverables, and issue resolution.
• Evaluate and implement new upstream technologies that strengthen mammalian cell culture and microbial fermentation capabilities.
• Maintain current knowledge through scientific literature, external meetings, and internal technical forums.
• Work a flexible schedule, including occasional work outside core hours or on weekends, when required to support time‑sensitive experiments.

Required:

• PhD in biochemical or chemical engineering, microbiology, cell biology, biotechnology, biochemistry, or a related discipline with at least five years of relevant experience; or an MS/BS with at least 10 years of relevant experience appropriate to the position.
• Demonstrated expertise in upstream bioprocess development, with deep hands‑on experience in at least one of…