Associate Lead I - Biomanufacturing, Compliance

Position Summary Work Schedule: Wednesday – Saturday, 2pm-12am Location: 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single‑use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics. Role Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause. Provide timely review of logbooks as needed to ensure data complies with cGMP expectations. Actively engage in Inspection Readiness activities and teams. Assist in tracking/monitoring and providing timely, accurate information regarding status of open investigations. Participate in initiatives to improve process compliance culture, including ongoing cGMP understanding and application, including self‑audit and CAPA programs. Participate in internal audits and assist in closure of applicable findings. Identify and assist with training issues, instruction problems, or new educational needs regarding specific employees or groups or equipment. Instruct personnel on communications, decisions, policies, and all matters that affect their performance, attitudes, and results as it relates to GMP compliance. Support authoring of Standard Operating Procedures (SOPs) for new processes, systems or technologies or when gaps are identified. Assist in identifying improvements for safety and provide on‑the‑floor manufacturing support. Other duties as assigned. Candidate Must have a minimum of a High School Diploma/GED with at least 4+ years of related experience or an Associate’s degree in STEM with 1+ years of related experience. No experience required with a Bachelor’s degree in STEM related field. Related experience includes proficiency in Microsoft Office and the ability to learn and use quality and scientific systems (e.g., TrackWise®, ComplianceWire®, JD Edwards®, Unicorn®). Applies cGMP principles and best practices to ensure compliant, high‑quality execution of procedures. Demonstrates foundational knowledge of manufacturing and laboratory operations, with the ability to learn new processes and techniques. Experience with deviation investigations, including corrective and preventive actions (CAPAs). Experience with authoring and editing SOPs and related documentation under guidance. Physical requirements: The candidate must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities. Benefits Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. 152 hours of PTO + 8 paid holidays. Generous 401(k) match. Medical, dental and vision benefits. Tuition Reimbursement. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. #J-18808-Ljbffr