Arvinas is a pharmaceutical company focused on developing new small molecules ‒ known as PROTACTM (PROteolysis TArgeting Chimera) protein degrader molecules ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. The proprietary PROTAC-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com.
The Director will serve as a core member of the development team and conduct formulation development and scale-up for Arvinas small-molecule drug candidates entering Phase I studies and beyond. Working closely with process chemistry, clinical supply logistics, and clinical development, the incumbent will be accountable for formulation and analytical development of clinical assets. Working through CDMOs, the incumbent will be responsible for formulation design as well as clinical supply manufacture, validation campaigns, and technology transfer. The candidate will be a process development expert with experience in developing and implementing 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.
- Provide technical expertise, and specialized knowledge in formulation development and drug product manufacturing to support the Arvinas portfolio of clinical drug assets.
- Apply scientifically-driven thinking to the development of formulations and products which meet pre-determined product profiles.
- 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.
- Provide technical input on requests-for-proposals, identification of, and selection of vendors for scale-up and manufacture of clinical formulations.
- Evaluate the activities and emergent data from on-going formulation development, manufacturing, and analytical work at CDMOs.
- Evaluate data associated with characterization of drug products and stability testing and assess suitability of a drug product for an intended purpose. Establish appropriate drug product specifications.
- Convert data on formulations/products into knowledge required for IND and NDA filings. Assist in drafting the relevant sections of these regulatory filings.
- Responsible for identifying drug product critical quality attributes
- Responsible for effective risk assessments/FMEA for manufacturing processes
- Interact effectively & build successful relationships with members of the Arvinas discovery, development, and project management staff. Assist in creating efficient process development practices within Arvinas.
- Minimum of a Master’s Degree in Chemistry, Pharmaceutics or Engineering
- 10+ years of relevant experience in industrial drug development is required
- Hands-on experience in formulation development, process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms of small molecules.
- Must be experienced in managing early and late stage programs as a drug product lead
- Familiarity with quality-by-design approaches to drug product development
- 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.
- Working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products
- Experience with creating RFPs, and working with CDMOs for formulation development, manufacturing of drug product, and analytical assays.
- Ability to multi-task and manage several projects in parallel, and effectively prioritize and deliver on short timelines.
- Proven ability to quickly adapt to changes in project direction
- Ability to forge cross-functional working relationships with internal and external project partners
- Excellent oral and written communications skills
- Proven ability to think creatively, and obtain solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement.
Please send CV and cover letter to: email@example.com
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