Stuart Hadley
Director Cmc @OMass Therapeutics
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WORK HISTORY
Director Cmc @OMass Therapeutics
Macclesfield, GB
Lead the planning and execution of the CMC strategy for all pipeline products.Development, scale-up, technology transfer and validation of chemical processes for APIs.Oversight of drug substance manufacturing.Formulation development (including bioavailability enhancement techniques) and manufacturing for clinical supply.Management of IMP supply chain including clinical trial packaging, labelling and distribution.Contributing to overall regulatory strategy, authoring/reviewing/managing the generation of IMPD/IND Module 3 sections and equivalent regulatory filings; and responding to queries.Selecting and managing multiple CDMOs and consultants to meet company objectives.
EDUCATION
University of Bradford
BSc.Hons, Chemistry with Pharmaceutical & Forensic Science
ABOUT STUART HADLEY
20+ years’ experience in the pharmaceutical industry in both scientific and commercial rolesMember of the Chartered Institute of Purchasing and Supply (MCIPS) and Association for Project ManagersExperienced leader of CMC development and manufacturingComprehensive understanding of the drug development processSignificant change and project leadership experienceEffective communicator, including presentation and contract negotiation skillsSpecialties: Pharmaceutical Development, CMC leadership, Pharmaceutical Development Outsourcing, Project & Portfolio Management, Strategic Sourcing, Contract Negotiation, Supplier Relationship Management, EHS/CR Due Diligence, Performance Management
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