Scott S.
Director, Clinical Manufacturing at Alexion Pharmaceuticals, Inc.
- Role
- Director, Clinical Manufacturing at Alexion Pharmaceuticals, Inc.
- Location
- New Haven, CT, US
- LinkedIn followers
- 500 followers
About Scott S.
Clinical and commercial manufacturing subject matter expert experienced in cell culture, purification, aseptic filling, quality, medical devices, pre-approval inspections, commissioning facilities, disposable technologies, combination products, and transfer of technology.Specialties: Operational Excellence, Experience in Lean Manufacturing, Kaizen events, MDI (manufacturing daily improvements) metrics, and 5S organizational methodology. White Belt Certified.Deviation Management: Versed in TrackWise and SmartSolve software applications as well as Root Cause Analysis, Cause and Effect Diagrams, and implementation of corrective and preventive actions
Experience
Director, Clinical Manufacturing
Jun 2021 — Present · New Haven, CT, US
Lead cross-functional teams of both internal and external stakeholders to ensure on time delivery and uninterrupted supply of clinical Drug Substance and Drug Products.Oversee manufacture of Drug Substance, Drug Product, and Devices for biologics as well as API for small molecule programs.Partner with peers in Commercial Supply Chain to plan seamless program transitions.Manage clinical Drug Substance and Drug Product production budget. Oversee expenditures and ensure adherence to budget. Prepare short and long term financial plans for production activities, present to finance and senior management on a regular basis.Collaborate with peers in clinical packaging/labeling and distribution to ensure continuous alignment of program needs and delivery timelines.Guide and Collaborate with internal/external technical groups to ensure on-time success of New Product Introduction and Technology Transfer activities, including handling and solving complex problems that may result in significant delays or inhibit program success.Work effectively with Development and Commercial Manufacturing to transition products to/from Clinical Manufacturing; implement solutions and best practices.Develop supply models based on the latest technological platforms and define manufacturing schedules based on overall program knowledge and capabilities, including but not limited to technology-specific limitations, expiration dating, manufacturing timelines, development activities, and regulatory requirements.
Education
University of Dayton
Bachelor in Science, Biology
1992 — 1996
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