Director / Principal Scientist, Biologics Drug Substance Commercialization (BDSC)
At a glance
AI generatedTL;DR
Join Our Company’s Manufacturing Division as a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC), where you will lead the upstream cell culture team, driving late-stage and commercial biologics programs. This senior role involves providing technical leadership for process development, validation, and technology transfer to ensure regulatory compliance and support global manufacturing. You’ll collaborate with cross-functional teams, manage a group of scientists, and foster innovation in antibody therapeutics and other complex modalities. Essential skills include expertise in cell culture process development, commercialization experience, and strong leadership abilities. Preferred qualifications involve hands-on work with advanced biologics, regulatory submissions, and lean principles. This position demands deep knowledge in upstream processing, analytical methods, and GMP standards within a dynamic environment focused on scaling up processes for global impact.
Skills
What you'll do
- Lead upstream and integrated drug substance teams for late-stage clinical and commercial biologics programs.
- Provide technical leadership in process characterization, validation, and technology transfer to manufacturing sites.
- Author and review regulatory documentation supporting biologics commercialization and licensure.
- Drive division-wide initiatives aligned with biologics manufacturing and commercialization strategy.
- Lead a team of upstream scientists, fostering innovation and operational excellence.
- Support the development and scale-up of multi-specific antibody therapeutics.
What we're looking for
- Deep technical expertise in cell culture process development and commercialization.
- Proven experience supporting biologics commercialization, including late-stage development and manufacturing.
- Strong leadership skills for managing a team of scientists and fostering innovation.
- Hands-on experience with technology transfer, scale-up, and validation of biologics processes.
- Demonstrated ability to prioritize and deliver complex objectives in fast-paced environments.
Employer
About MSD
MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.
MSD currently has 14 open roles on FindRole.
Listed pay typically runs $117,000–$184,200 across 13 roles with salary data.
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