Director, Drug Product Development and Manufacturing

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 two clinical-stage programs: ARV-110, which is being developed as a potential treatment 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 200 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.

Position Summary

The Director will serve as a core member of the development team and conduct manufacturing development and scale-up for Arvinas small-molecule drug candidates entering Phase 2 studies and beyond. Working closely with process chemistry, clinical supply logistics, clinical operations, and quality assurance, the incumbent will be accountable for formulation/process development of clinical assets as they are brought into later stage development.  Working through CDMOs, responsibilities include clinical supply manufacture, scale-up activities, validation campaigns, and technology transfer. The candidate will be a process development expert with direct experience in optimizing and scaling-up robust formulations applicable to solid oral and parenteral dosage forms of small molecules.  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. The work location can be at our headquarters in New Haven, CT or remote. 

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Provide technical expertise, and specialized knowledge in process/formulation development and drug product manufacturing to support the Arvinas portfolio of later stage clinical drug assets.
• Apply scientifically driven thinking (Quality-by-Design) to the development and manufacture of formulations and products which meet pre-determined product profiles.
• Working with internal stakeholders, craft and distribute request-for-proposals (RFP) 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.
• As the primary contact with external contractors, manage day-to-day interactions to ensure that deliverables are completed as contracted.
• Through the services of contract manufacturing vendors, maintain accountability for development, optimization, scale-up, and technology transfer of scalable and robust processes applicable to oral and parenteral drug products. Responsible for technical leadership in preparation of engineering, clinical, and validation batches.
• Evaluate data associated with characterization and stability testing of drug products that assess suitability of a drug product for an intended purpose.  Establish appropriate specifications for drug product and their intermediates.
• 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.
• Convert data on formulations/products into knowledge required for regulatory filings. Draft the relevant sections of these regulatory filings.
• Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.

Qualifications

• Hands-on experience in formulation development, process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms of small molecules. Experience with management of all stages drug product development and manufacturing.

• A successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors. Good communication skills and ability to influence team comprising of external partners.

• Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to manufacture and quality testing of pharmaceutical products.

• Proven ability to think creatively and obtain solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement.

• Must be an experienced leader in a cross functional setting that requires frequent interaction with internal and external stakeholders relevant to early & late-stage product development.
• Entrepreneurial with self-starting personality; ability to manage multiple responsibilities simultaneously and quickly adapt to changes in project direction.
• Excellent oral and written communications skills

• Ability to work in a fast-paced, highly motivated work environment.
• Desire to roll up sleeves and dig in.  Confidence in own abilities to get things done.

Education

• An advanced degree in Chemistry, Pharmaceutics, or Engineering
• 10+ years relevant experience in CMC operational roles in Pharma / Biotech environments.

#LI-Remote

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