Catalent - Winchester, VA
posted 3 months ago
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 will 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 requires performing technical reviews of client documents, including but not limited to specification/validation reports/test methods/compliance reports, to perform gap analysis with respect to methods/instruments/procedures for completing methods transfers from clients or their third-party labs with guidance from supervisors/senior team members. The Associate Scientist will analyze finished products, in-process materials, and raw materials according to the assigned specifications, methods, and protocols according to cGLP and cGMP. They will document, process, and report the data as applicable to support the team in a timely fashion. A basic understanding of cGLP/cGMP and analytical chemistry is essential, along with the ability to perform analysis using KF titrations, Dissolutions, IR, UV spectrophotometers, and LC for dissolutions, assays, impurities, and data processing using Empower. The role also involves troubleshooting instrumentation issues and proposing method improvements during method feasibility work and compendial method evaluations. The Associate Scientist will perform stability testing on developmental, clinical, and registration batches as per approved test methods/stability protocols and escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members. Other duties may be assigned as necessary.