The Research Scientist will serve as a core member of the development team and execute formulation strategy for Arvinas drug candidates. The incumbent will be responsible for executing exploratory research and development studies, as well as supporting clinical supply manufacture through in-house efforts and CDMOs. In addition, the successful candidate will support the in vivo group in preparing dosing solutions and troubleshooting vehicle failures. He/She will work closely with in vivo biology, process chemistry, clinical supply logistics, and clinical to develop vehicles and formulation to advance assets into preclinical and clinical studies. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
Responsibilities include research on and development of formulations to support enabling exploratory and pre-clinical animal studies, as well as clinical studies. This will be accomplished through a blend of in-house and out-sourced activities. In addition to a hands-on component, the incumbent will be responsible for preparing requests-for-proposals, and monitoring the activities of several formulation development and manufacturing organizations. The incumbent will provide critical analysis of on-going development activities and continually assess the suitability of a particular formulation for its intended use. A key activity of this role will be the assembly/evaluation of pharmaceutical study data and drafting of the relevant sections of INDs and NDAs.
- Design, carry out, and interpret preformulation studies on new and potential drug candidates, with the purpose of defining their physicochemical and biopharmaceutical properties relevant to oral and parenteral administration
- Develop fit-for-purpose formulations to enable exploratory and enabling animal studies
- Provide technical expertise, and specialized knowledge in formulation development and drug product manufacturing to support the Arvinas portfolio of drug candidates.
- Work closely with in-life groups to develop and prepare formulations suitable for use in drug discovery pharmacology, pharmacokinetic, and toxicology studies
- Assist in the preparation of requests-for-proposals, selection of vendors, and monitoring the activities/emergent data of/from formulation development and manufacturing organizations.
- Apply scientifically-driven thinking to the development of formulations and products which meet pre-determined product profiles.
- Evaluate data associated with characterization of drug products and stability testing and assess suitability of a drug product for an intended purpose.
- Convert data on formulations/products into knowledge required for IND and NDA filings. Assist in drafting the relevant sections of these regulatory filings.
- Works closely with peers on project teams to seamlessly and expeditiously advance Arvinas assets into the clinic
- BS/MS in Pharmaceutical / Medicinal / Physical / Analytical Chemistry
- 6-10 years of experience in industrial drug development is required
- Hands-on experience with formulation development/manufacturing
- An understanding of basic medicinal chemistry and biopharmaceutical principles as they apply to drug discovery and development
- A willingness to take on challenging problem statements and acquire/apply the skills necessary to address them
- Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation and/or progression of a study and resolve the issues in a timely and creative fashion
- Experience with creating RFPs, and working with CDMOs for pre-formulation, formulation development, and manufacturing of drug product
- Working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products
- Ability to effectively prioritize and deliver on tight timelines
- 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
- Good oral and written communications skills
- Experience in using computers and databases for data collection, compilation, analysis, and information dissemination
- Proficient with MS Word, PowerPoint, Excel
Job Requirements – Personality
- Conduct themselves in an ethical, honest and accountable manner
- Ability to establish and maintain effective working relationships
- 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
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