Centessa Pharmaceuticals

• Oversee the implementation of end-to-end CMC strategy across Centessa’s development programs • Translate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functions • Develop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationships • Proactively identify and mitigate technical, production, and supply chain risks • Act as the CMC team representative member in cross-functional developmental teams • Oversee outsourced manufacturing activities, including CDMO contract negotiations and performance management • Ensure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches. • Manage the development of budgets and timelines for CMC operations and report regularly to leadership • Drive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programs • Interface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plans • Assist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+) • Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activities • Oversee technical transfer activities of API and drug product for supply chain resilience • Supervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distribution • Oversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirements • Manage analytical method development and validation for starting materials, in-process controls, and final release and stability • Participate in manufacturing site visits and pre-approval inspection readiness initiatives • Identify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirements