Principal Scientist, Upstream Development
$173.2k - $272.6kMerck
Merck seeks a Principal Scientist for upstream biologics process development within their research organization. The role involves leading cell culture process development for clinical and commercial biotherapeutics, advancing platform strategies, and supervising junior scientists while collaborating across internal and external partners.
Responsibilities
- Lead upstream process development for first-in-human and commercial biologic processes with focus on yield, robustness, and scalability
- Provide technical direction for process characterization, commercialization, and regulatory filing activities toward PPQ and BLA approvals
- Champion process improvement initiatives and upstream platform technical strategy advancement
- Supervise, coach, and educate junior scientists while facilitating cross-functional team collaboration
- Evaluate and integrate new technologies through external partnerships with academia, industry, and vendors
Requirements
- Ph.D. with 8+ years industry experience, or Master's with 10+ years, or Bachelor's with 14+ years in chemical/bioengineering or related field
- Proven track record in upstream process and technology development with scientific publications and presentations
- Hands-on experience with CHO fed-batch cell culture and bioreactor systems across scales
- Working knowledge of cell culture media, CHO biology, DOE statistics, and computational fluid dynamics
- Ability to direct planning, execution, and documentation of cell culture process development stages
- Demonstrated staff development and team leadership capabilities in matrixed environments
- Knowledge of biologics CMC development cycle and regulatory pathways
Vacancy posted a month ago
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