Associate Director / Director, External API Manufacturing and Supply

Company: Arvinas Inc.
Location: New Haven
Posted on: November 22, 2021

Job Description:

Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Targeted protein degradation is an entirely new approach to drug development - one that could dramatically change the lives of patients who have few or no therapeutic options. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas' PROTAC-- Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas' pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which has demonstrated safety and efficacy in men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which has the potential to be a best-in-class estrogen receptor-targeting therapy for patients with breast cancer. #TeamArvinas is made up of more than 200 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 purpose - to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It's an exciting time to be in drug development and it's an exciting time to be at Arvinas. But don't just take our word for it - here's what Arvinas employees are saying . For more information, please visit . Position Summary We are currently seeking an experienced and strategic individual to join the Technical Operations manufacturing and supply team at Arvinas. The 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 Senior Director, External API Manufacturing and Supply and will work closely with the members of Chemical Process R&D. In addition, the Associate 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 Senior Director, External API Manufacturing and Supply and will be located at our headquarters in New Haven, CT or may 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. Education
    • An MS/Ph.D in Chemistry or Chemical Engineering or related technical field and 10+ years relevant experience in CMC operational roles, preferably in a bio-tech environment. #LI-Remote 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 . Arvinas is an Equal Opportunity Employer.

Keywords: Arvinas Inc., New Haven , Associate Director / Director, External API Manufacturing and Supply, Executive , New Haven, Connecticut