Small Molecule CMC Leader - Senior Director
Scorpion Therapeutics
Position Summary Lead CMC (Chemistry, Manufacturing and Controls) for a Medicines Development and Innovation programme, from Commit to Phase 2 (C2P2) through Phase 3 (P3)/commercial process development, global file review/launch, and completion of major clinical & CMC/SC lifecycle work. Key Responsibilities Engage with early CMC 6–12 months prior to C2P2; take accountability from early CMC leader at C2P2. Own development, industrialisation, and lifecycle delivery for the assigned medicine modality (small molecule, biopharm or CGT). Define DS/DP/device/analytical/manufacturing/supply chain/quality and CMC regulatory approaches; generate options/recommendations balancing time, cost, resources and risk. Deliver CMC/SC strategy and plan via CMC/SC matrix team and external development/manufacturing network; manage integration, alignment, risks/issues; secure Specialist Sign Off (SSO) and SME inputs. Monitor scope changes/threshold breaches and resolve via governance (CMC board, DRB, PIB). During P3: develop PPQ and PAI readiness; ensure continuous process verification (CPV) and pre-approval inspection readiness; enable global commercial file/launch. Post-launch: identify and define lifecycle medicine development and commercial needs; capture plans in further medicine CMC/SC master strategy and ToA contract. Provide "voice of the physical product" and "voice of the project"; transition accountability to Medicine Supply Chain Leader (MSCL) after ToA. May line manage MDI Directors; lead interfaces; lead CMC/SC due diligence; and/or lead systems/process updates. Qualifications / Required Skills BSc or PhD in life sciences, (bio)chemical engineering, pharmaceutical sciences or relevant area. Significant experience in pharmaceuticals, CMC and supply chain. Director/Senior Director experience. Experience developing/presenting/defending P2, P3 and lifecycle CMC/SC strategies, plans and resources to governance. Experience influencing very senior internal/external leaders, including US/EU/Japan/China health authorities, in marketing review and pre-approval inspection settings. Leadership of international, multi-disciplinary P2/P3/lifecycle CMC/SC teams (including CDMOs); success through P3, file, launch and early lifecycle. People development experience (mentor/coach/teacher) in matrix and/or line leadership. Strong cross-functional leadership in a matrix environment. Breadth/depth in late-stage CMC and supply chain aspects, regulatory/quality standards, clinical/commercial supply for small molecule/biopharm/CGT; tech transfer, process scale-up, external manufacturing. Experience authoring/contributing to CMC regulatory submission sections. Strong decision-making, problem-solving and communication skills for technical and non-technical audiences. Location Ware, United Kingdom Upper Providence, USA (hybrid; not fully remote). #J-18808-Ljbffr Scorpion Therapeutics
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