Senior Director, External API Manufacturing and Supply

Role Summary

Senior Director, External API Manufacturing and Supply leads the strategy and execution of drug substance development and manufacturing, with direct oversight of contract manufacturing organizations (CDMOs). The role drives API supply chain design, RFPs, contracting, and technical oversight to advance assets from early development through commercialization, ensuring compliance with SOPs and regulatory requirements. Location: New Haven, CT or remote within the U.S.; reports to the Executive Director, External API Manufacturing and Supply.

Responsibilities

• Design and implement a comprehensive API supply chain strategy for specific projects.
• Craft and distribute RFPs to CDMOs to access intermediates and API supplies for the Arvinas pipeline.
• Evaluate proposals and quotes against project requirements for quantity, quality, and timing.
• Coordinate with Process R&D to select the best service providers to meet project needs.
• Develop master service agreements and contracts with internal/external legal resources to reflect deliverables.
• Serve as primary contact with contractors, managing day-to-day interactions to ensure contracted deliverables.
• Provide technical oversight of contracted suppliers in API-related deliverables.
• Drive forecast planning and inventory management of project intermediates and APIs; implement risk-mitigation strategies.
• Participate in budget planning for API campaigns and track expenditures relative to budget.
• Communicate production schedules to Project Management and the project team as part of Integrated Development Plans.
• Manage CMC API Supply Chain interfaces with Drug Product Supply, Quality Assurance, and Regulatory Compliance.
• Establish detailed plans guiding chemical development from early development to commercialization, ensuring quality and regulatory requirements are satisfied.
• Participate in strategy discussions to align decisions with business direction and processes.
• Lead data collection from suppliers and contribute to drafting of INDs, NDAs, and amendments.

Qualifications

• A successful history of hands-on chemical development and scale-up.
• Proven track record in the RFP/contracting process with detailed technical oversight of third-party contractors.
• Experience with management of all stages of API development and manufacturing.
• Comprehensive working knowledge of cGMPs and regulatory guidance related to manufacture and quality testing of pharmaceutical products.
• Demonstrated experience in inventory management and forecasting.
• Ability to prioritize and deliver on tight timelines; strong problem-solving, organizational, and project management skills.
• Excellent oral and written communications; proficient with MS Word, PowerPoint, Excel.
• Strong leadership, planning, negotiation, and presentation skills; experience communicating complex information to senior management and regulatory agencies.
• Ability to multi-task and manage several projects in parallel; ability to build cross-functional relationships with internal and external partners.
• Proactive at identifying issues and resolving them creatively and timely.
• Must be legally authorized to work in the US without employer sponsorship now or in the future.
• Physical/work environment requirements include lifting 15/30 pounds as needed and working in office/lab/home environments with PPE as appropriate.

Education

• An MS/Ph.D. in Chemistry or Chemical Engineering or related technical field with 15+ years of relevant experience in CMC operational roles, preferably in a biotech environment.