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Executive Director, Manufacturing Operations - T1D

Scorpion Therapeutics

General Summary: Build and lead a global external manufacturing network for Type 1 Diabetes cell therapy programs. Provide strategy, governance, and operational oversight of Contract Manufacturing Organizations (CMOs), ensuring quality, reliability, and scalability for clinical development and commercialization. Key Duties and Responsibilities: External Manufacturing Strategy & Network Leadership: Define/execute external manufacturing strategy; build resilient CMO/supplier network; lead CMO governance; establish partnership models. CMO Partnership & Oversight: Oversee manufacturing execution at CMO sites; drive safety/quality/delivery/cost performance via KPIs; maintain on-site presence; identify and mitigate supply/operational risks. Tech Transfer & Operational Readiness: Partner with MSAT and CMC for tech transfer; oversee validation, comparability, and lifecycle management; plan to enable pivotal trials and commercial launch. Quality & Compliance: Ensure GMP compliance; support inspection readiness and regulatory filings; manage deviations, change control, and CAPA. Supply Chain & Integration: Integrate CMOs into end-to-end supply chain; ensure chain-of-identity and chain-of-custody; manage key supplier relationships. Financial & Investment Stewardship: Oversee budgets/contracts/capital investments; ensure ROI; negotiate/manage CMO agreements. Cross-Functional Leadership: Partner with Technical Operations/CMC/Regulatory/Quality/Supply Chain; support IND/BLA/MAA; lead team and develop capabilities. Knowledge and Skills: GMP and global regulatory knowledge (FDA, EMA, ICH); multi-site tech transfer/process validation/lifecycle management; advanced therapy supply-chain familiarity; lead through influence in matrixed environments; partnership orientation; strategic execution. Education and Experience: MS/PhD (or equivalent) in life sciences/engineering; 15+ years biopharma manufacturing with senior leadership; deep CMO/external network experience in GMP; cell/gene therapy experience strongly preferred; track record supporting clinical and commercial supply. Benefits: Annual bonus; annual equity awards. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 1 day ago
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