Project Manager, CMC Technical Operations & Quality
Arvinas is a clinical-stage biopharmaceutical 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 developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 350 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 www.arvinas.com.
If you have experience in project management and drug development and are excited about joining a company that is positioning itself to finding solutions for patients with an unmet medical need through its novel PROTAC® Discovery engine, then this might be for you!
Arvinas is seeking a CMC & Quality Project Manager with experience in drug development to support its CMC and Quality teams. The successful candidate will provide project management support to CMC work streams in early-stage asset development by driving execution of the CMC plan. The project manager will also support the Quality team for clinical assets with project management tools to ensure a coordinated and timely management of document reviews, and timely release of materials to vendor and clinical sites.
The position will be remote/hybrid-based and reports to the Associate Director, Project Management-R&D Tech Ops.
Key responsibilities of this role include, but are not limited to:
- Translate the CMC strategy for early-stage development assets to create an operational integrated plan and ensure a successful execution of the plan.
- Leverage portfolio and project management tools to track plans, milestones, and risks, and ensure appropriate communication within CMC, and with discovery, and asset transition teams.
- Manage all integrated CMC meeting logistics including the meeting minutes to align the team on decisions and actions agreed upon by the team.
- Create and manage a plan of Quality-related deliverables for clinical-stage assets to ensure a coordinated review of documents between the CMC and Quality teams, and timely release of materials to clinical and vendor sites.
- Identify and highlight risks and propose recommendations to mitigate risks.
- Manage the ‘Book of Work’ for CMC early development assets and Quality-related work streams.
- Business acumen with 5 + years experience in project management and drug development within the pharmaceutical/biotechnology industry
- Working knowledge or experience with Quality systems, GMP and FDA/regulatory requirements
- Prioritization and risk management with good judgement call for escalation
- Strong team player with an ability to drive execution and decision making
- Bachelor’s degree in Life Sciences or Pharmacy, or higher
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