Andrew J. Lepage
Biopharma Technical Leader | Tech Transfer, External Manufacturing, GMP, PPQ | Known for leading cross-functional teams to drive operational excellence, supply continuity, and CMC success
- Role
- Manager, Process Engineering & Msat at Thermo Fisher Scientific
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Andrew J. Lepage
Results-driven biopharmaceutical leader with 15+ years of experience in technical organizations, with a strong focus on external manufacturing strategy, technology transfer, and GMP operations. I specialize in driving operational excellence through data-informed decision-making and cross-functional collaboration.Notable achievements include improving manufacturing efficiency and boosting product yield by 30% for an ocular gene therapy program through targeted process optimization. I bring deep expertise in managing complex CMO relationships, leading OOS investigations, and executing successful PPQ campaigns to support both clinical and commercial supply.Passionate about building strong partnerships across Manufacturing, Quality, and Supply Chain to ensure seamless tech transfers and robust, compliant manufacturing operations.
Experience
Manager, Process Engineering & Msat
Sep 2023 — Present
Led technical and scientific teams responsible for the successful execution of gene therapy tech transfers at a global CDMO site. Oversaw critical GMP equipment readiness and inspection support while driving operational excellence through digital tools and streamlined workflows- Directed qualification and maintenance of GMP-critical equipment to ensure operational and regulatory compliance- Implemented a digital tracker for technical assessments, significantly improving deviation closure rates- Co-led facility decommissioning, achieving >90% task completion in just 6 weeks- Led technical response efforts during client and Health Authority inspections, contributing to successful outcomes.
Education
University of Maine
Bachelor of Science, Chemical Engineering
Skills
- Statistical Software
- Mathcad
- Microsoft Office
- Testing
- Chromatography
- Autocad
- Minitab
- Matlab
- Medical Devices
- Pharmaceutical Process Development
- Microsoft Excel
- Powerpoint
- Pi Processbook
- Filtration
- Statistical Data Analysis
- Jmp
- Spc
- Data Analysis
- Gxp
- Pharmaceutical Manufacturing
- Iso 13485
- Iso 9001
- Unit Operations
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