Associate Lead I - Biomanufacturing, Compliance

About Site Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

Summary We have an opportunity for an Associate Lead I - Biomanufacturing, Compliance to join our team. This role supports cGMP manufacturing operations and ensures compliance with Standard Operating Procedures, regulatory, and client requirements. The position plays a key part in maintaining quality and compliance standards while contributing to continuous improvement initiatives. It offers the chance to work in a dynamic environment dedicated to patient safety and operational excellence. Shift: Wednesday - Saturday, 11:00pm - 9:00am ($5,000 Sign-On Bonus Available) Location: Madison, WI 100% Onsite The Role Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause. Provide timely review of logbooks to ensure data complies with cGMP expectations and assist in tracking and monitoring open investigations. Participate in initiatives to improve process compliance culture, including ongoing cGMP understanding, 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 for employees or equipment. Inform personnel of communications, decisions, and policies affecting performance and GMP compliance. Support authoring Standard Operating Procedures (SOPs) for new processes, systems, or technologies or when gaps are identified. Assist in identifying safety improvements and provide on-the-floor manufacturing support. Other duties as assigned. The Candidate Minimum Requirements High School Diploma or GED with at least 4 years of related experience, or an Associate’s degree in a STEM field with 1 year of related experience, or a Bachelor’s degree in a STEM field with no experience required. Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and 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.

Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents, and 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. Preferred Skills & Background GMP experience in