GroupLeader-AnalyticalDevelopment

**Group Leader - Analytical Development** **Position Summary:** * **Work Schedule:** M-F 8am-5pm * 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s. **Catalent Pharma Solutions in Madison, WI is hiring a Group Leader - Analytical Development.** The The Analytical Development team is responsible for evaluating client analytical methods and/or optimizing/developing methods required to support cell line, upstream, and downstream development, and transferring them to the QC department for phase appropriate validation. The team is also responsible for characterizing primary and high order structures; confirming product comparability across scale and establishing product degradant profiles and specifications for reference standards of mRNA proteins/mAbs generated at Catalent’s Madison site. The team executes on this by applying the concepts of analytical quality be design (AQbD)in compliance with FDA and other regulatory agency requirements and in conformance with the site’s GMP quality systems. Success requires that laboratories and instruments are maintained in accordance with Good Manufacturing, Laboratory, and Documentation Practices (GM/L/D/P), schedules/timelines/milestones for method development and sample testing are met, and that the integrity of generate data is confirmed. The team’s role is therefore central to the success of projects that enter cell line and process deve