The Manufacturing Associate will serve as CMO Project Manager for prescription drug product candidates and non-prescription products . The successful candidate will be an experienced CMO project manager and critical thinker who will serve as a key contributor at an animal healthcare company. The successful candidate will manage all aspects of CMO relationships, including sourcing CMOs, preparing RFPs, negotiating terms and determining budgets. The incumbent will manage development, optimization and production of formulated materials, adhere to strict timelines and partner closely with regulatory.
Qualifications include a minimum of 3-5 years’ experience managing CMO relationships, including sourcing CMO’s negotiating terms and managing development, optimization and production of formulated materials, 2+ years of experience managing multi-million dollar budgets, PhD or MS degree with 2-4 years of experience (or a BS degree with 3-5 years’ experience) in formulation science from an accredited institution with strong emphasis in one or more of the following disciplines: biotechnology, biology, pharmaceutics, medicinal chemistry, chemical engineering, polymer science or pharmacokinetics. Other requirements include hands on manufacturing experience at all levels (lab, pilot, full commercial(, proven understanding of cGMP, breadth and depth of understanding of the pharmaceutical/animal health industry (API, DP, packaged product formats) with an emphasis on API experience, working knowledge of CMC Guidance for veterinary products, regular travel to domestic and global CMO’s, experience working independently and in multi-disciplinary, geographically dispersed teams, strong analytical and problem solving skills, ability to learn quickly and adapt to change, good communicator, ability to travel in the US as well as travel internationally and be able to overcome obstacles.
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