Director, Vaccine Upstream Process & Commercialization

Merck; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck is seeking a Director to lead the Vaccines Drug Substance Commercialization (VDSC) upstream process development and commercialization. You will guide senior scientists and engineers in mammalian cell culture, live-virus vaccines, microbial fermentation, and scale-up strategies across multiple facilities.

You will drive process control, validation, technology transfer, and lifecycle management while aligning with regulatory expectations.

Qualifications

• Education: Ph.D. or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry or related field.
• Experience: 10+ years leading end-to-end vaccine/biologic CMC process development with late-stage focus.
• Leadership: 5+ years leading CMC projects and directing cross-functional teams.
• Technical: Deep subject matter expertise in biologics or vaccine processing (large molecules).
• Regulatory: Experience authoring CMC documentation including PPQ, risk assessments, control strategies, and filings.
• Soft Skills: Excellent communication and matrix-leadership capabilities.

Responsibilities

• Serve as senior technical authority for upstream vaccine process development and commercialization across culture, fermentation, and scale-up.
• Drive process control and validation strategies for internal and external GMP sites, aligning with regulatory expectations.
• Direct development and scale-up across varied platforms and equipment and ensure representative scale-down models.
• Align departmental goals with enterprise priorities and manage budgets and headcount.
• Provide guidance across vaccine upstream process development and lifecycle management.

Skills

Analytical Thinking

GMP

People Leadership

Process Development

Upstream Process Development

Vaccine Manufacturing

Regulatory Documentation

Strategic Planning

Education

Ph.D. or Master’s in Chemical Engineering / Bioengineering / Biological Engineering / Biochemistry

Job description

Merck is seeking a Director to lead the Vaccines Drug Substance Commercialization (VDSC) upstream process development and commercialization. You will guide senior scientists and engineers in mammalian cell culture, live-virus vaccines, microbial fermentation, and scale-up strategies across multiple facilities.

You will drive process control, validation, technology transfer, and lifecycle management while aligning with regulatory expectations.