VP of Operations & Biomanufacturing – 30 Years of Global CMC & Facility Leadership
- Samantha Wein
- Apr 16
- 2 min read
Updated: Apr 24
Executive Summary: We are representing a premier Biopharma Operations Executive with a 30-year track record in the manufacturing of microbial, mammalian, and viral products. This leader has overseen large-scale (4000L) and small-scale (50L) operations, navigating the complexities of CDMO leadership, Government Contracting (BARDA/DoD), and Facility Design. They are a subject matter expert in bringing life-saving vaccines and oncology therapeutics from tech transfer through to BLA filing and commercial launch.
Core Competencies & Technical Mastery:
Full-Scale Biomanufacturing: Expertise in Upstream (Stainless & SUBs), Downstream, and Supply Chain for API and Drug Product.
Capital Project Leadership: Directed the design and remodel of multiple facilities, including a $105M Vaccine Center of Innovation and an $80M Pilot Plant.
Regulatory & Quality Excellence: Veteran of FDA and QP inspections; deep fluency in cGMP, IND/BLA submissions, and responding to agency inquiries.
Diversified Therapeutic Reach: Unparalleled experience with infectious disease targets (Ebola, Zika, SARS, Anthrax) and high-impact Oncology (Melanoma, Ovarian, Prostate).
Financial Stewardship: Managed departmental budgets exceeding $4M and facility/project budgets up to $35M.
Professional Milestones:
VP of Operations (High-Growth CDMO): Revitalized organizational resource planning and implemented emerging technologies to streamline cost-effective manufacturing.
VP of Manufacturing & Technical Operations: Led health, safety, and operational effectiveness for a leading bio-services organization, bridging the gap between R&D and commercial execution.
Senior Director of Operations (Global Vaccine Leader): Spearheaded supply chain and procurement for viral/non-viral multiproduct operations, managing SAP implementation and SOX compliance.
Federal Program Leadership: Developed and integrated upstream/downstream operations for major clinical vaccine programs in partnership with the NIH and National Research Centers.
Why Hire This Candidate?
In an era where "speed-to-market" is everything, this candidate offers the rare ability to build the plane while flying it. They have spent three decades refining the "Basis of Design" for the industry's most critical facilities. Whether you are a startup scaling to your first clinical batch or a global pharma firm needing a steady hand for a multi-site integration, this leader brings "Zero-Failure" experience to the table.
Interested in this candidate? To request a resume or schedule an interview, please book a consultation with our team or contact us directly using the links below.
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