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.
We are currently seeking a strong analytical chemist to join the Analytical Research and Development organization within Technical Operations at Arvinas. The incumbent will serve as a core member of a multidisciplinary project team and directly impact execution of the analytical programs for both active pharmaceutical ingredient and drug product development and manufacturing. 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 analytical method development, conducting complex analytical investigations along with CDMO oversight. This position will work closely with the members of Chemical Process Development, Formulation R&D, and External Manufacturing and Supply. In addition, the incumbent will work closely with project teams to 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 Director, Analytical R&D and is located at our Headquarters in New Haven, CT or may be performed remotely from a location in the US..
Key responsibilities of this role include, but are not limited to:
- Provide technical oversight of contracted suppliers in execution of analytical-related deliverables, including phase-appropriate method development and validation.
- Manage analytical section of all Arvinas GLP and toxicology studies: build overall analytical strategy for in-vivo/in-vitro GLP programs; work with external lab for method development, qualification and troubleshooting.
- Establish standard monitoring program for reference standards, impurity markers, deuterated material, etc.
- Manage, review analytical data and reports, track release, stability, and reference material testing, and lead laboratory investigations along with QA. Analyze stability trends through statistical and scientific tools.
- Work with External Supply and Manufacturing, craft the relevant technical sections of RFPs to commission analytical development at CDMOs.
- Evaluate proposals for technical content matching the capabilities of the supplier with the project requirements.
- Work with External Manufacturing and Supply select the best providers of service to meet project needs.
- Ensure that validation work and testing are conducted in a manner compliant with cGMPs and regulatory requirements
- Lead the collection of relevant analytical data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.
- Evaluate quotes from vendors and recommend instrument acquisition as subject expert.
- Communicate analytical workplans and strategies with functional group leaders to ensure project timelines are met.
- 10-15 years of relevant experience in analytical development in the pharmaceutical or bio-tech environment.
- A successful track record of managing small molecule analytical deliverables of in all stages of API and Drug Product development and manufacturing. Late-phase experience is preferred.
- Strong understanding of spectroscopy, NMR, and mass spectrometry.
- A competent grasp of organic chemistry and functional group reactivity.
- Experience with solid state analysis is a plus.
- A solid understanding of chemical process development and formulation development
- A successful track record in the RFP/contracting process along with detailed technical oversight of third-party contractors.
- 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
- 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
- Strong project planning, 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
A Ph.D or M.S. in organic/analytical chemistry or related technical field.
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