Arvinas

Senior Director, External API Manufacturing, Supply

Arvinas

full-time

Posted on:

Location Type: Hybrid

Location: New Haven • Connecticut • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • 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.

Requirements

  • 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.
  • 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.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
API developmentchemical developmentscale-upinventory managementforecastingcontracting processtechnical oversightGood Manufacturing Practicesregulatory guidanceproject management
Soft skills
problem-solvingorganizational skillscommunication skillsleadershipnegotiationpresentation skillsmulti-taskingattention to detailcross-functional collaborationproactive issue resolution