Open Positions: 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.
The Director will serve as a core member of the Technical Operations team and conduct manufacturing development, scale-up and technology transfer for Arvinas small-molecule drug candidates. Working also at the interface of API and drug product development, this individual will reach back to the last steps of API synthesis in ensuring a seamless process considering API material attributes in concert with drug product processing steps. Working closely with process chemistry, formulation development, quality assurance and our CDMO partners, the incumbent will be accountable for process development, technology transfer and process validation of late-stage assets as they are considered for commercialization. The candidate will be a process development expert with direct experience in optimizing and scaling-up robust formulations (often involving enabling technologies such as spray drying) 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 Executive Director, Drug Product Development, External Manufacturing and Supply. The work location can be at our Headquarters in New Haven, CT or remote.
Key responsibilities of this role include, but are not limited to:
- Provide technical expertise, and specialized knowledge in process development, technology transfer and process validation of drug product manufacturing processes to support Arvinas portfolio of late-stage drug assets.
- Working with internal stakeholders, contribute to development of request-for-proposals (RFP) to CDMOs to provide robust industrializable processes of required scale proven through comprehensive validation plans for late stage 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.
- Through the services of contract manufacturing vendors, apply scientifically driven thinking (e.g., Quality by Design) for optimization, scale-up, and technology transfer of scalable and robust processes applicable to oral and parenteral drug products.
- Evaluate data associated with scale-up and validation batches of drug products to assess suitability of drug product processes. for an intended purpose. Contribute to establishing appropriate specifications for drug product and drug product intermediates.
- Convert data on formulations and processes into knowledge required for regulatory filings. Draft the relevant sections of these regulatory filings.
- Participate in budget-planning for late-stage 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.
- Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.
- Hands-on experience in formulation process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms including utilization of PAT tools where applicable.
- Thorough knowledge of the relationship between material properties, characterization and functional requirements. Application of Material Science understanding to development and scale-up of formulation processes involving enabling technologies to overcome compound limitations such as poor solubility (e.g., spray-drying, melt-extrusion, nanosuspensions, lipidic formulations) will be a plus.
- An understanding of crystallization processes, isolations and drying of products (process intermediates and APIs), targeting optimization of the processes and properties of the resulting materials (e.g., control over polymorphism, crystal habit, particle size, etc.) is a plus.
- A successful track record in the 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.
- 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.
- An advanced degree in Chemistry, Pharmaceutics, or Engineering
- 10+ years relevant experience in CMC operational roles in Pharma / Biotech environments.
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