Open Positions: Senior Research Scientist / Research Investigator, Chemical Processes
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.
This scientist will serve as a core member of the development team and assist in the development of the overall chemical development strategy for Arvinas’ drug candidates. The incumbent will be responsible for conducting chemical research and development studies within synthetic routes to the API, as well as providing chemical development input to CDMOs working in the API supply chain. This position encompasses route scouting, process development, and manufacturing of drug substances in the Arvinas portfolio to support, pre-clinical, clinical, and commercial activities. They will work closely with medicinal chemistry, formulation R&D, drug product manufacturing and pre-clinical operations to 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 Director, Chemical Process R&D. This role is based out at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Research on synthetic routes, development and optimization of chemical processes, technology transfer, and manufacturing of drug substance supplies to support pre-clinical and clinical studies
- Support in-house research and out-sourced drug development and manufacturing activities
- Contribute to requests-for-proposals and monitor the activities of several drug substance development and manufacturing organizations
- Provide critical analysis of on-going development activities and continually assess the suitability of a particular route, chemical process, or bulk drug for its intended purpose
- Evaluate process robustness and analytical profiles
- Work collaboratively with medicinal chemists to ensure a smooth transition of synthetic route knowledge from discovery to development
- Support chemical process development and scale-up activities through targeted, high value, in-house, process research and development studies
- Provide input to CDMOs conducting route scouting, process development, and scale-up activities throughout different stages of development (pre-clinical through Phase 3 and commercialization)
- Contribute to requests-for-proposals and evaluation of potential CDMOs
- Review all reports, COAs and related documentation to build in-house understanding of products and processes
- Convert data on processes and products into knowledge required for IND and NDA filings. Contribute to the drafting the relevant sections of these regulatory filings
- Evaluate data associated with processes and products and assess suitability for an intended purpose and commercialization potential
- Work closely with peers on project teams, especially formulation R&D, pre-clinical operations, and drug product manufacturing to seamlessly and expeditiously advance Arvinas’ assets into the clinic and on to the commercial market
- Maintain a network of and interfaces with a variety of subject matter experts on topics relevant to process research, development, and manufacturing of APIs
- D. in Organic Chemistry is preferred
- A minimum of 5-10 years of experience in chemical process research and development in the pharmaceutical industry.
- Demonstrated success in route scouting, process development, technology transfer, and manufacturing of small molecule APIs
- Experience with hands-on lab experimentation in of all stages of chemical development from route scouting to commercial manufacturing
- Ability to be proactive in identifying issues and hurdles that may hinder the effective process development and scale-up
- Knowledge of the content of RFPs and prior experience in working with CDMOs for route scouting, process development and scale-up of drug substances
- A working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products
- Ability to establish and maintain effective working relationships
- Ability to effectively prioritize and deliver on tight timelines
- 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
- An ability to contribute innovative solutions to problems
- Experience in communicating/presenting complex information to senior management.
- 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
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