Associate Director, Clinical Manufacturing

This is what you will do: 

The Associate Director is a cross‑functional leader responsible for overseeing Alexion’s external clinical manufacturing operations for small‑molecule, biologics, and gene therapy drug substance and drug product. This role manages internal and external teams, drives manufacturing and program timelines, and ensures reliable clinical supply. Success is measured by effective execution with CMOs, achievement of supply and financial targets, and leadership of complex, high‑impact programs across the organization. 

You will be responsible for: 

• Lead internal and external cross‑functional teams to ensure timely, uninterrupted clinical supply of small‑molecule, biologics, and gene therapy drug substance and drug product. 

• Oversee manufacturing activities for small‑molecule, biologics, and gene therapy programs in partnership with PDCS leadership. 

• Guide technical teams to achieve successful New Product Introduction and Technology Transfer, including resolving complex issues that could impact timelines. 

• Partner with Development and Commercial Manufacturing to support smooth product transitions to/from Clinical Manufacturing. 

• Collaborate with Supply Planning to develop supply models and manufacturing schedules that reflect program requirements, technical capabilities, and regulatory considerations across all modalities, including gene therapy. 

• Lead vendor identification and selection for novel technologies and complex manufacturing processes, including viral vector, AAV, or other gene therapy platforms. 

• Negotiate master supply agreements, project plans, and statements of work with external partners. 

• Recommend strategic clinical manufacturing plans across all phases of clinical development, including gene therapy programs requiring specialized capabilities. 

• Manage drug substance and drug product budgets, including externally sourced gene therapy manufacturing. 

• Support process improvement initiatives, tech transfers, and scale‑up activities, including for gene therapy modalities with unique regulatory and technical needs. 

• Partner with Quality Assurance to ensure timely batch release, deviation resolution, and CAPA implementation. 

• Provide regular operational updates to senior leadership. 

• Establish and track KPIs to assess CMO performance, clinical material utilization, and performance across gene therapy manufacturing partners. 

• Participate in business reviews, joint steering committees, and cross‑functional project team meetings. 

• Travel up to 10% as required. 

You will need to have: 

• 8+ years of experience in cGMP manufacturing for small‑molecule, API, biologics, and/or gene therapy drug substance or drug product. 

• Proven experience managing CMOs and providing technical oversig