Principal Scientist, Upstream Process Development

MSD • Rahway, NJ

1d

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company's biologics pipeline, working with Discovery, Pre-clinical and Early Development to develop processes and supply clinical trials, and with Manufacturing Division partners to commercialize and launch new products. The organization also handles late-stage process development and characterization in preparation for commercial manufacturing.

The Principal Scientist will lead cross-functional teams developing CMC packages for pipeline assets and collaborate with Bioprocess Development colleagues on technical strategy for next-generation processing. The role contributes to pipeline CMC development through upstream cell culture process development and transfer to clinical and commercial manufacturing sites, and develops strategies for process and pipeline-facing innovation. The successful candidate is expected to provide scientific leadership, collaborate across functions, mentor junior scientists, lead projects, communicate effectively, and use data science and digital tools to address complex problems.

Requirements

• Ph.D. with 6 or more years of industry experience, or a Master's degree with 8 or more years of industry experience, in Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• A 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 processing and analytics.
• Understanding and hands-on experience with cell culture bioreactors, including microbioreactors, bench-scale and pilot-scale bioreactors, and scale-up and technology transfer activities.
• Working knowledge of cell culture media, CHO cell biology and metabolism, DOE statistics, and computational fluid dynamics.
• Ability to work in a matrixed team environment 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.
• Demonstrated initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop staff, maximize use of talent, actively guide career development, and build strong collaborative teams.
• Effective organizational and multitasking skills, scientific leadership, and strong written and oral communication abilities.

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 process analytical technology efforts and computational fluid dynamics.
• Experience leading cross-functional program development teams.
• A track record of leveraging data science and digital tools to deliver impactful solutions to complex problems.
• Strong external presence through scientific excellence.

Responsibilities

• Lead biologic upstream 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 new technologies and industry strategies relevant to the company.
• Collaborate with academia, industry partners, and vendors to develop, innovate, and adopt process technologies with broad impact to projects or platforms.
• Keep current with external patent and literature developments; present and publish externally and pursue patenting strategies.
• Mentor and educate junior scientists.
• Contribute to CMC development of the company's pipeline, including development of cell culture processes and transfer to clinical and commercial manufacturing sites.
• Develop strategies for process and pipeline-facing innovation.
• Direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
• Develop staff to maximize talent utilization, guide career development, and build collaborative teams.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal