Assoc. Director/Director, CMC External Manufacturing & Supply

Arvinas is a pharmaceutical company focused on developing new small molecules ‒ known as PROTACTM (PROteolysis TArgeting Chimera) protein degrader molecules ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. The proprietary PROTAC-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com.

We are currently seeking an experienced and strategic individual to lead CMC manufacturing and supply 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 and drug product 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 VP of CMC and will work closely with the heads of Chemical Process R&D and Formulation R&D.  In addition, the 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.

Primary Responsibilities

  • Design, lead, and implement a comprehensive API and DP supply chain strategy at Arvinas.
  • Working with the heads of Process and Formulation R&D, craft and distribute request-for-proposals to CDMOs to access intermediate, API, and DP 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 the heads of Process and Formulation 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 and DP-related deliverables.
  • Drive forecast planning and inventory management of all intermediates, APIs, and DPs to meet near-term and long-term goals. Incorporate risk-mitigation strategies.
  • Lead budget-planning for API and DP 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 Arvinas assets.
  • Manage the CMC Supply Chain interfaces with Clinical Supply, Clinical Operations, Quality Assurance, and Regulatory Compliance.
  • 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 to enable drafting of INDs, NDAs, and associated amendments.

Qualifications

  • A Ph.D in Chemistry, Pharmaceutics, or Chemical Engineering or related technical field and 10+ years relevant experience in CMC operational roles, preferably in a bio-tech environment.
  • A successful history of hands-on chemical, and/or formulation 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 API and DP 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

Please send CV and cover letter to: careers@arvinas.com

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