Arvinas is a clinical-stage biotechnology company leading the way in targeted protein degradation therapeutics. 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 three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being co-developed and commercialized by Arvinas and Pfizer as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 400 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 – learn more about life at Arvinas and what employees have to say. For more information, please visit www.arvinas.com.
We are currently seeking a talented and experienced individual to join the Technical Operations Drug Product Development, External Manufacturing and Supply team at Arvinas. The Associate Director will serve as a member of a multidisciplinary CMC Coordination team (CMC-CT) and directly impact timing, and execution of both drug product development and manufacturing. As the operational lead on assigned projects, 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. The individual will work closely with the members across Technical Operations, Quality Assurance and Project Management. Working through the CMC Coordination team and line management, the Associate Director will 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, Drug Product Development, External Manufacturing and Supply, and can be located at our headquarters in New Haven, CT or can be performed remotely from within the United States.
Key responsibilities of this role include, but are not limited to:
- As an operational lead on projects, be actively engaged in selection, oversight and management of drug product development and manufacturing activities at CDMO partners.
- Design and implement a comprehensive DP supply chain strategy for specific projects at Arvinas.
- Working with the internal team, 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. Enable selection of 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 Arvinas lead at vendor meetings, ensure efficient meetings, action follow-ups and streamlined documentation flow. 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
- Collaborate with Supply planning function in 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 CMC-CTas part of project Development Plans for specific Arvinas assets.
- Manage the Technical Operations drug product supply chain, interfaces with Clinical Supply, Quality Assurance, and Regulatory Compliance.
- Lead the collection of relevant data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.
- 10+ years relevant experience in CMC operational roles, preferably in a bio-tech environment.
- Must have a successful history of hands-on solids formulation development and scale-up. Experience of working on enabling technologies for delivering poorly soluble compounds in a plus.
- 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.
- 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
- 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.
- MS/PhD in Pharmaceutical Sciences, Engineering or related technical field required.
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