Director, Vaccine Upstream Commercialization

MSD; West Point (PA); Vor Ort; USD 173.000 - 273.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Zusammenfassung

MSD is seeking a Director to lead the Vaccines Drug Substance Commercialization (VDSC) upstream organization. You will provide senior technical direction for vaccine upstream processes, drive cross-site process development, validation, and tech transfer, and champion lifecycle management for late-stage programs.

You will manage a ~30-person team, partner with internal and external stakeholders, ensure regulatory alignment, and deliver robust drug substance manufacturing while controlling

Qualifikationen

• PhD or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry or a related field.
• 10+ years of experience leading end-to-end vaccine and/or biologic CMC process development, with emphasis on late-stage projects, regulatory filing and approvals.
• 5+ years of experience leading CMC projects and directing transversal or functional process development teams.

Aufgaben

• Serve as the senior technical authority for upstream vaccine process development and commercialization across mammalian cell culture, live-virus vaccines, microbial fermentation, media and feed strategy, bioreactor engineering and validation.
• Drive process control and validation strategies to deliver robust drug substance processes across GMP sites.
• Direct development and scale-up across varied platforms and equipment including AMBR and pilot-scale systems; ensure scale-down models are representative.
• Align departmental goals with broader enterprise priorities to support an evolving pipeline.
• Own accountability for team resource allocation, budgets, and headcount projections.
• Provide expert guidance across vaccine upstream process development and lifecycle management for large molecules.
• Coach and develop talent; foster a high-performance culture and succession planning.
• Evaluate team performance through formal appraisal processes and development support.
• Champion safety and EHS compliance through training and Gemba walks.

Kenntnisse

Analytical Thinking

GMP Knowledge

Process Development

People Leadership

Strategic Planning

Technical Leadership

Upstream Process Development

Vaccine Manufacturing

Ausbildung

PhD or Master's in Chemical Engineering or related field

Jobbeschreibung

MSD is seeking a Director to lead the Vaccines Drug Substance Commercialization (VDSC) upstream organization. You will provide senior technical direction for vaccine upstream processes, drive cross-site process development, validation, and tech transfer, and champion lifecycle management for late-stage programs.

You will manage a ~30-person team, partner with internal and external stakeholders, ensure regulatory alignment, and deliver robust drug substance manufacturing while controlling