We are seeking an accomplished and strategic leader to serve as Vice President of Manufacturing, responsible for overseeing multi-site biologics manufacturing operations, including both Drug Substance and Drug Product facilities. The ideal candidate will bring extensive experience in biologics manufacturing, including large-scale commercial operations, clinical supply, and technology transfers.
This role requires demonstrated success managing large teams across multiple sites and a strong track record in operational excellence, regulatory readiness, and organizational scale-up.
Responsibilities:
- Provide executive leadership and oversight for multiple manufacturing facilities across Drug Substance and Drug Product operations
- Define and execute strategies for operational scalability, performance excellence, and site readiness to meet clinical and commercial demands
- Collaborate with executive and functional leaders to align manufacturing goals with corporate objectives
- Lead day-to-day biologics manufacturing operations including upstream, downstream, formulation, aseptic fill/finish, and lyophilization
- Ensure manufacturing operations meet or exceed quality, safety, compliance, and performance standards
- Oversee site expansion initiatives, including facility upgrades, capacity increases, and workforce development
- Drive efficient technology transfers from process development to commercial manufacturing
- Lead process validation and ensure seamless scale-up for late-stage clinical and commercial supply
- Ensure alignment among MSAT, engineering, and operations teams for successful technical execution
- Maintain continuous inspection readiness and compliance with global cGMP standards
- Serve as executive sponsor during regulatory inspections and audits (FDA, EMA, etc.)
- Champion a quality- and compliance-driven culture rooted in accountability and performance
- Build and mentor high-performing leadership teams across manufacturing locations
- Promote a culture of ownership, continuous improvement, and professional development
- Lead change management, organizational design, and workforce scaling initiatives
- Develop and manage CAPEX and OPEX budgets, headcount plans, and operational metrics
- Drive cost-efficiency and process excellence through Lean manufacturing principles and Six Sigma tools
- Oversee long-range manufacturing capacity planning aligned with pipeline and commercial requirements
Experience/Qualifications
- Bachelor’s degree in engineering, life sciences, or related field; advanced degree (MS, PhD, or MBA) strongly preferred
- 20+ years of experience in biopharmaceutical manufacturing, with at least 10 years in senior leadership roles overseeing Drug Substance and Drug Product operations
- Proven experience in multi-site manufacturing leadership, including site start-up, expansion, and commercial readiness
- Deep knowledge of biologics operations including upstream/downstream processing and aseptic fill/finish
- Experience in both clinical and commercial biologics manufacturing environments is desirable
