Clinical Operations/Project Management

Robert Kaster


Robert Kaster brings more than 30 years of pharmaceutical/biopharma experience from both small and large organizations (including Wyeth and DuPont Pharma) and has been consulting since 2007.  He holds a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science (University of the Sciences in Philadelphia) and is a registered pharmacist.  Rob is also an American Society for Quality (ASQ) Certified Quality Auditor (CQA).   His background includes CMC Regulatory Affairs, CMC drug product formulation development/manufacturing and GXP Quality Assurance.  Strengths include CMC regulatory submission compilation (US/ex-US) and CMC FDA strategy/meetings as well as CMC product/process development/validation clinical through commercial manufacturing.  His Quality experience includes QA/Compliance program development/oversight, extensive auditing (facility-Pharma and CMO/CRO, documents, regulatory submissions, PAI-readiness), generation of SOPs, protocols, validations, CAPA assessment and quality agreements.  Rob has successfully worked with numerous multi-disciplinary teams, project lead on many occasions with a focus on client’s needs and deliverables.