Director, Vaccines Drug Substance Commercialization - Upstream

Director-level position leading the upstream vaccine drug substance commercialization team of ~30 scientists and engineers at Merck's manufacturing division in Pennsylvania. Provides technical and strategic oversight for late-stage pipeline and commercial vaccine process development, from cell culture and fermentation through scale-up, technology transfer, and regulatory submission.

Responsibilities

• Serve as senior technical authority for upstream vaccine process development and commercialization strategy
• Drive process control and validation strategies ensuring alignment with regulatory expectations and lifecycle plans
• Direct scale-up and technology transfer across varied platforms and manufacturing sites
• Manage team resource allocation, capital, and consumable budgets with accountability for financial targets
• Champion EHS compliance, safety culture, and talent development within the department

Requirements

• Ph.D. or Master's in Chemical Engineering, Bioengineering, Biological Engineering, Biochemistry, or related field
• 10+ years leading end-to-end vaccine and biologic CMC process development with late-stage project focus
• 5+ years directing CMC projects and managing large process development teams
• Deep expertise in biologics and vaccine processing, cell culture, and fermentation commercialization
• Proven experience authoring PPQ, risk assessments, control strategies, and regulatory filings
• Exceptional interpersonal, communication, and matrix-leadership skills with mentoring capability