Principal Engineer-Drug Substance with MS-Chemistry or Chemical Engineering with one year experience in pharmaceutical development wanted by J-Star Research, Inc. in South Plainfield, NJ to perform multi-step drug substance synthesis and crystallization and provide quantities in the range from milligrams to kilograms compliance with cGMP principles and FDA and ICH regulatory requirements; Conduct polymorph screening, salt screening and pre-formulation study for active pharmaceutical ingredients (APIs) in support of patent filing and protection, downstream drug development; Utilize experimental and process simulation/modeling approaches to characterize and solve process challenges across multiple unit operations; Develop continuous manufacturing process for intermediate and API with process analytical technologies (PATs); Execute validated test methods for pharmaceutical raw materials for strength, impurities, and identity using solid-state characterization instruments, HPLC, GC, LC/MS, spectroscopy, and/or traditional wet chemical testing methods; Write/review developmental chemistry, process optimization and process scale-up reports to support regulatory requirement for CMC (Chemistry, Manufacturing and Control) sections of INDs/NDAs.  Must have knowledge and skills in synthetic chemistry, solid-form screening and crystallization; application of continuous manufacturing; cGMP regulatory.  Mail resume to J-Star Research, 3001 Hadley Road, Unit 1, So. Plainfield, NJ 07080

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