Senior Director, External API Manufacturing and Supply New

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs currently enrolling: ARV-102 for the treatment of patients with neurodegenerative disorders,ARV-393 for the treatment of patients with relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas, and ARV-806, a KRAS G12D PROTAC for the treatment patients with solid tumors with KRAS G12D mutations.

On August 8th 2025, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for vepdegestrant- an investigational, orally bioavailable PROTAC estrogen receptor degrader- for its use as a monotherapy in the treatment of adults with estrogen receptorpositive (ER+), human epidermal growth factor receptor 2negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

In April 2024, Arvinas entered into a transaction with Novartis, including a global license agreement for the development and commercialization of the clinical stage PROTAC androgen receptor protein degrader ARV-766 for the treatment of prostate cancer. The transaction closed in May 2024.

#TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it

For more information, please visit www.arvinas.com.

Senior Director, External API Manufacturing and Supply

Position Summary

We are currently seeking an experienced and strategic individual to join the Technical Operations manufacturing and supply team at Arvinas. The Sr. Director will serve as a core member of a multidisciplinary project team and directly impact strategy, timing, and execution of both drug substance development and manufacturing. A key responsibility of this role will be technical oversight of the associated CDMOs. The qualified individual will have a track record of accomplishment in preparing RFPs, CDMO selection, contracting, and CDMO oversight. This position reports to our Executive Director, External API Manufacturing and Supply and will work closely with the members of Chemical Process R&D. In addition, the Sr, Director will work closely with project teams to develop and execute a streamlined program to advance assets into clinic and then into commercialization. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.

This position reports to the Executive Director, External API Manufacturing and Supply and will be located at our headquarters in New Haven, CT or can be performed from a remote location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Design and implement a comprehensive API supply chain strategy for specific projects at Arvinas.
• Working with Process R&D, craft and distribute request-for-proposals to CDMOs to access intermediates and API supplies to enable the Arvinas pipeline.
• Evaluate proposals and quotes matching the capabilities of the supplier with the project requirements in terms of quantity, quality, and timing of deliverables.
• Working with Process R&D select the best providers of service to meet project needs.
• Working with internal and external legal resources craft master service agreements and contracts to reflect required deliverables.
• As the primary contact with the contractors, manage day-today interactions to ensure that deliverables are completed as contracted.
• Contribute to technical oversight of contracted suppliers in execution of API-related deliverables.
• Drive forecast planning and inventory management of project intermediates and APIs to meet near-term and long-term goals. Incorporate risk-mitigation strategies.
• Participate in budget-planning for API campaigns and track all spend relative to budget.
• Communicate production schedules to Project Management and the project team as part of project Integrated Development Plans for specific Arvinas assets.
• Manage the CMC API Supply Chain interfaces with Drug Product Supply, Quality Assurance, and Regulatory Compliance.
• Establish detailed plans to guide project chemical development activities from early development to commercialization, ensuring all quality and regulatory requirements are proactively satisfied.
• Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.
• Lead the collection of relevant data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.

Qualifications

• A successful history of hands-on chemical development and scale-up.
• A successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors.

• Experience with management of all stages of API development and manufacturing.
• Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to manufacture and quality testing of pharmaceutical products.
• Demonstrated experience in inventory management and forecasting.
• Ability to effectively prioritize and deliver on tight timelines.
• Outstanding problem-solving abilities.
• Detail-oriented, with good organizational and project management skills
• Good oral and written communications skills.
• Proficient with MS Word, PowerPoint, Excel.
• Strong leadership, project planning, negotiation and presentation skills.
• Significant experience in communicating/presenting complex information to senior management and regulatory agencies.
• Ability to multi-task and manage several projects in parallel, paying attention to detail.
• Ability to forge cross-functional working relationships with internal and external project partners.
• Ability to be proactive in identifying issues and hurdles that may hinder the effective progression of an asset and resolve the issues in a timely and creative fashion.
• Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future.
• The duties of this role are generally conducted in a combination of office, lab and home office environments. Employees must be able, with or without an accommodation to lift/carry 15/30 pounds unassisted/assisted; work comfortable in a controlled environment with and around biological, infectious and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Education

• An MS/Ph.D in Chemistry or Chemical Engineering or related technical field and 15+ years relevant experience in CMC operational roles, preferably in a bio-tech environment.

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status.