AssociateScientist

**Associate Scientist** **Position Summary** * Typical working hours are Monday - Friday 8 AM - 5 PM. * This position is 100% on-site in Winchester, Kentucky. Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. The Associate Scientist work/assist on method development, method transfer, method verification and method validation under appropriate guidance along with routine release and stability testing in support of clinical development and registration activities required for the regulatory submissions. **The Role** * Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP. Document, process, report the data as applicable to support the team in timely fashion. * Perform analysis as required to support assigned testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC to perform dissolutions/assays/BU/CU, impurities and data processing using Empower and document per applicable test methods/specification/protocols etc. * Use Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/dissolutions/impurities etc. Knowledge of Trackwise for managing deviations and investigations and ability to manage /handle with guidance from supervisors/senior team members. * Troubleshoot and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members. Methods