Manager Analytical Research and DevelopmentLocation: CTCheck out for all of our openingsH1B Transfer available for the right candidate!
This scientist will serve as a core member of the development team and assist in the development of the overall chemical development strategy. 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 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 CT.Principal ResponsibilitiesKey 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 studiesSupport in-house research and out-sourced drug development and manufacturing activitiesContribute to requests-for-proposals and monitor the activities of several drug substance development and manufacturing organizationsProvide critical analysis of on-going development activities and continually assess the suitability of a particular route, chemical process, or bulk drug for its intended purposeEvaluate process robustness and analytical profilesWork collaboratively with medicinal chemists to ensure a smooth transition of synthetic route knowledge from discovery to developmentSupport chemical process development and scale-up activities through targeted, high value, in-house, process research and development studiesProvide 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 CDMOsReview all reports, COAs and related documentation to build in-house understanding of products and processesConvert data on processes and products into knowledge required for IND and NDA filings. Contribute to the drafting the relevant sections of these regulatory filingsEvaluate data associated with processes and products and assess suitability for an intended purpose and commercialization potentialWork closely with peers on project teams, especially formulation R&D, pre-clinical operations, and drug product manufacturing to seamlessly and expeditiously advance assets into the clinic and on to the commercial marketMaintain a network of and interfaces with a variety of subject matter experts on topics relevant to process research, development, and manufacturing of APIsQualificationsPh.D. in Organic Chemistry is preferredA 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 APIsExperience with hands-on lab experimentation in of all stages of chemical development from route scouting to commercial manufacturingAbility to be proactive in identifying issues and hurdles that may hinder the effective process development and scale-upKnowledge of the content of RFPs and prior experience in working with CDMOs for route scouting, process development and scale-up of drug substancesA working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical productsAbility to establish and maintain effective working relationshipsAbility to effectively prioritize and deliver on tight timelinesOutstanding problem solving abilitiesDetail-oriented, with good organizational and project management skillsGood oral and written communications skillsProficient with MS Word, PowerPoint, ExcelAn ability to contribute innovative solutions to problemsExperience in communicating/presenting complex information to senior management.Ability to multi-task and manage several projects in parallel, paying attention to detailAbility to forge cross-functional working relationships with internal and external project partners
Relocation is provided for this role.
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#LI-KL1Type: Direct HireCategory: Biotech Company