Associate Director, Clinical Manufacturing
About The Position
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.
Requirements
- 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 oversight, including experience with gene therapy manufacturing, viral vector processes, or related novel modalities.
- Experience with device/combination products, biologics, cell and gene therapies, or other emerging technologies strongly preferred.
- Demonstrated ability to influence decision makers internally and externally.
- Strategic thinker with strong cross‑functional insight and the ability to evaluate and mitigate complex manufacturing risks.
- Experience leading cross‑functional project teams (e.g., CMC teams).
- Demonstrated leadership in ambiguous or novel technical areas, including gene therapy programs with evolving regulatory frameworks.
- Strong understanding of cGMP and modality‑specific regulatory requirements, including those applicable to gene therapy.
- Strong project management, communication, and negotiation skills.
- Proactive in identifying and mitigating supply risks.
- BS in engineering or science (or equivalent experience).
Nice To Haves
- Experience in additional functions such as Development, Commercial Manufacturing, Business Development, Marketing, or Alliance Management.
- Advanced degree preferred.
Responsibilities
- 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.
Benefits
- Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
- Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
- If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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What This Job Offers
Job Type
Full-time
Career Level
Director
