With over 25 years in BioPharma, Paul Andrea has experienced the significant development and transformation of the industry and specifically GMP Manufacturing.
Paul began his career at Genentech. In his 18 years there, he acquired technical and process expertise in Seed Train Operations, Equipment Preparation, Facility Management, Scheduling, Process Development, Formulation and Fill/Finish. He took opportunities in GMP Production Facilities in South San Francisco and Vacaville and the Fill/Finish Facility in Hillsboro, Oregon. After departing from Genentech in 2012, Paul and his family moved to South Korea where he was part of the first expatriate hires for Samsung Biologics. Paul led the Drug Product Organization from equipment qualification to Regulatory Approval. He also hired and trained over 100 Korean University Graduates with virtually no experience in GMP Manufacturing and more specifically, Aseptic Operations. His additional responsibilities included representing the Drug Product Department as the primary interface for the Business Development group, interacting with potential new clients, performing facility fit evaluation, facility design, new product introduction, and Quality and Compliance support for all components of Drug Product Manufacturing.
After departing Samsung Biologics in 2017, Paul started TAF Group LLC in 2018. His focus is to ensure the Manufacturing of Parenteral Drugs is performed in a safe and compliant manner following Global Regulatory requirements. Whether it is an audit of your Sterility Assurance Program, performing due diligence visits for potential CDMO selection, writing SOPs and protocols, or working side by side on the shop floor with the technical team, Paul will approach all activities with professionalism, enthusiasm, and a will do attitude so that all objectives are accomplished.
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