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 U.S. manufacturing site for large‑scale oral dose forms, offering integrated analytical and development services. With 28 years of expertise in product development, technology transfer, and commercial manufacturing, and roots in industry‑leading Glatt technology, the Associate Scientist will perform analytical research and development work in the Analytical R&D Department.

• Analyze finished products, in‑process materials, and raw materials according to assigned specifications, methods, and protocols under cGLP and cGMP. Document, process, and report data to support timely team delivery.
• Perform analysis to support testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC for dissolutions, assays, BU/CU, impurities, and data processing using Empower, documenting per applicable test methods, specifications, and protocols.
• Use Empower software to create instrument, processing, and report methods, and perform online Empower calculations for assay, dissolution, and impurities. Familiarity with Trackwise for managing deviations and investigations is required, with guidance from supervisors.
• Troubleshoot and propose method improvements during method feasibility work or compendial evaluation for assay, impurities, dissolution, etc., with senior guidance.
• Assist team members in method transfers, compendial verifications, or full method validations, including forced degradation and mass balance/peak purity to demonstrate stability‑indicating nature per USP, ICH Q2, and SOP guidelines.
• Perform stability testing on developmental/clinical/registration batches as per approved methods and protocols, reporting and documenting per applicable specifications. Escalate any OOS/OOT/atypical or trending results to supervisors or team members.
• Other duties as assigned.

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or Life Sciences (preferred in Analytical Chemistry).
• At least one year of experience in the pharmaceutical industry and one additional year in analytical testing/research using HPLC/GC/UV, etc.
• Understanding of analytical chemistry calculations such as concentrations, molarity, Beer’s Law, and reference‑standard purity.
• Basic knowledge of chromatographic techniques (LC/GC/dissolution) and spectroscopic analysis (UV).
• Demonstrated knowledge of ICH guidelines (Q1, Q2, Q3, etc.) and other regulatory guidelines.
• Adherence to SOPs related to DEA‑scheduled drugs, safety, waste management, and housekeeping; participation in process improvement initiatives.
• Experience with lifting liquid containers and objects greater than 50 lb, maintaining a clean laboratory environment, and safely handling glass canisters, chemicals, and required equipment.

• Employee Resource Groups focused on diversity and inclusion.
• Tuition reimbursement to support career advancement.
• Generous 401(k) match.
• 152 hours accrued PTO plus 8 paid holidays.

Catalent is an Equal Opportunity Employer, including disability and veterans.