Open Positions: Senior Manager/ Associate Director, CMC External Drug Product Manufacturing and Supply
Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ‒ known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ‒ 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. Our 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.
We are currently seeking an experienced and strategic individual to join the CMC manufacturing and supply team at Arvinas. The Associate Director will serve as a core member of a multidisciplinary project team and directly impact strategy, timing, and execution of both drug product development and manufacturing. A key responsibility of this role will be program 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, CMC External Manufacturing and Supply and will work closely with the members of Formulation 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, CMC External Manufacturing and Supply, and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Design and implement a comprehensive DP supply chain strategy for specific projects at Arvinas.
- Working with Formulation R&D, craft and distribute request-for-proposals to CDMOs to access clinical drug product 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 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-to-day interactions to ensure that deliverables are completed as contracted.
- Contribute to technical oversight of contracted suppliers in execution of DP-related deliverables.
- Ensure outsourced operations are conducted compliant with cGMPs and regulatory requirements
- Drive forecast planning and inventory management of drug product supplies to meet near-term and long-term goals. Incorporate risk-mitigation strategies.
- Participate in budget-planning for 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 specific Arvinas assets.
- Manage the CMC drug product supply chain interfaces with Clinical Supply, 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 and contribute to drafting of INDs, NDAs, and associated amendments.
- Participate in development of a vendor list, spanning a range of formulation technologies, vetted and organized according the key attributes to facilitate the identification and selection of drug product partner.
- Must have a successful history of hands-on formulation development and scale-up
- Demonstrate a successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors
- Experience with management of all stages drug product 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
- Experience in contributing to and review of regulatory submissions required.
- Demonstrated experience in inventory management and forecasting.
- Ability to effectively prioritize and deliver on tight timelines
- Must have 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
- An MS/PhD in Pharmaceutical Chemistry or Engineering or related technical field and 10+ 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.