The Director will serve as a core member of the development team and lead the overall chemical development strategy for Arvinas’ drug candidates. The Director will be responsible for executing all research and development studies, as well as API supply manufacture through CDMOs. The Director will provide strategic and technical leadership in route scouting, process development, and manufacturing of drug substances in the Arvnias portfolio to support, pre-clinical, clinical and commercial activities. He/She will work closely with medicinal chemistry, formulation R&D, drug product manufacturing and pre-clinical operations 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.
Responsibilities include 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. This will be accomplished exclusively through out-sourced activities. In addition to technical leadership, the incumbent will be responsible for preparing requests-for-proposals, negotiating contracts, and directing and monitoring the activities of several drug substance development and manufacturing organizations. The incumbent will 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. A key activity of this role will be the evaluation of process robustness and analytical profiles as well as drafting of the relevant sections of INDs and NDAs. In addition, the incumbent will be expected to provide technical insights and support for new product development to meet corporate goals and objectives.
- Work collaboratively with medicinal chemists to ensure a smooth transition of synthetic route knowledge from discovery to development.
- Provide strategic leadership, technical expertise, and specialized knowledge in chemical process development and scale-up to support the Arvinas’ portfolio of drug candidates.
- Provide technical leadership and guidance to CDMOs conducting route scouting, process development, and scale-up activities throughout different stages of development (pre-clinical through Phase 3 and commercialization)
- Prepare requests-for-proposals, negotiate contracts, and monitor the activities of several CDMOs.
- Review all reports, COAs and related documentation to ensure that results are accurately reported and conform to quality unit requirements
- Convert data on processes and products into knowledge required for IND and NDA filings. Drafts 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.
- Coordinate importation (when necessary) and shipping of drug substance from manufacturer to other sites
- Ph.D. in Organic Chemistry
- 15 years or more in the pharmaceutical industry with a minimum of 10 years in chemical process research and development
- Demonstrated success in route scouting, process development, technology transfer, and manufacturing of small molecule APIs.
- Experience with creating RFPs, negotiating contracts and managing CDMOs for route scouting, process development and scale-up of drug substances.
- Both hands-on experience with process development/manufacturing and technical leadership of groups engaged in same.
- Comprehensive 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
- Strong leadership, project planning, negotiation and presentation skills as well as an ability to contribute innovative solutions to problems
- Experience with management of all stages of chemical development from route scouting to commercial manufacturing
- Significant experience in communicating/presenting complex information to senior management and regulatory agencies.
- 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
Job Requirements – Personality
- Conduct themselves in an ethical, honest and accountable manner
- Ability to work in a fast-paced, highly-motivated work environment
- Entrepreneurial with self-starting personality; ability to prioritize and manage multiple responsibilities simultaneously
- Enthusiastic desire to roll up sleeves and dig in. Confidence in own abilities to get things done.
- Able to meet tight deadlines on multiple priorities.
- Strong analytical skills with attention to detail and accuracy
- Customer focused with strong team work, interpersonal and communication skills
- Requirement to maintain a high level of confidentiality
- Ability to develop solutions to problems and implement them.
New Haven, CT
Please send CV and cover letter to: firstname.lastname@example.org.