POSITION SUMMARY

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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.
Shift: Monday-Friday 8 AM-5 PM. This position is 100% on-site in Winchester, Kentucky.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

• Perform technical review of client’s documents as required including but not limited to specification/validation reports/test methods/compliance reports etc. to perform gap analysis with respect to methods/instruments/procedures etc. for completing methods transfers from client’s/or their third-party labs with guidance from supervisors/senior team members.
• 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. with guidance from senior team members.
• 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 and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members.
• Perform/assist team members in method transfers, Compendial verifications or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP <1224>, <1225>, <1226> ICH Q2 etc.)/SOPs with guidance from the supervisors/senior team members.
• Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols. Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.
• Other duties as assigned.