Principal Scientist, Upstream Process Development

MSD • Rahway, NJ

2d • $173,200 - $272,600 • Onsite

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the biologics pipeline, working with Discovery, Pre-clinical and Early Development to rapidly develop processes and supply clinical trials. The organization also conducts late-stage process development and characterization in preparation for commercial manufacturing, in partnership with the Manufacturing Division.

The Principal Scientist will lead cross-functional teams in developing CMC packages for pipeline assets and collaborate with Bioprocess Development colleagues on technical strategy for next-generation processing across early- and late-stage clinical development. The role contributes to upstream process development and transfer to clinical and commercial manufacturing sites, and develops strategies for process and pipeline-facing innovation. It calls for scientific leadership, organization and multitasking, strong written and oral communication, cross-functional collaboration, mentoring, project leadership, and scientific excellence. Leveraging data science and digital tools to solve complex problems is a distinguishing qualification.

Requirements

• Ph.D. with 6+ years of industry experience, or a Master’s degree with 8+ years of industry experience, in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Experience mentoring and educating junior scientists.
• Proven accomplishments in upstream process and technology development, with a strong scientific publication and presentation record.
• Experience in CHO fed-batch cell culture and working understanding of downstream processing and analytics.
• Hands-on experience with cell culture bioreactors, including microbioreactors, bench-scale, and pilot-scale bioreactors, as well as scale-up and technology transfer.
• Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics, and computational fluid dynamics.
• Ability to work in a matrixed team 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 model qualification, and process characterization.
• Initiative, creativity, and innovation in problem solving.
• Ability to develop staff, guide career development, and build strong collaborative teams.
• Required skills include biologics, bioreactors, biotherapeutics, cell culture process development, cell line development, combination products, CFD, FEA, pharmaceutical process development, process characterization, process development, product development lifecycle, regulatory filings, and technology transfer.

Nice To Haves

• 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 and media/solution chemistry.
• Background in data science approaches related to cell culture and predictive modeling, such as metabolic flux analysis, omics, and machine learning; experience integrating PAT efforts and computational fluid dynamics.
• Experience leading cross-functional program development teams.

Responsibilities

• Lead upstream biologic process development for first-in-human and commercial processes, developing high-yield, robust, and scalable cell culture processes.
• Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to support successful PPQs and BLAs.
• Advance upstream platform process technical strategy and champion process improvement initiatives.
• Initiate collaborations to assess relevant new technologies and industry strategies.
• Collaborate with academia, industry partners, and vendors to develop, innovate, and adopt process technologies with broad project or platform impact.
• Monitor the external patent and literature environment; present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.
• Direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Develop staff, maximize talent utilization, guide career development, and build collaborative teams.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree