Associate Lead I - Biomanufacturing, Compliance

Catalent • Madison, WI

3d • Onsite

About The Position

Catalent’s Madison, Wisconsin site is a biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. The approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development. It uses flexible single-use systems and supports clinical manufacturing scales from 50 to 4,000 liters. The site also houses Catalent’s GPEx® and GPEx® Lightning technologies. A 2025 expansion increased capacity and added equipment and approximately 200 jobs.

The Associate Lead I - Biomanufacturing, Compliance supports cGMP manufacturing operations and ensures compliance with Standard Operating Procedures, regulatory requirements, and client requirements. The role helps maintain quality and compliance standards and contributes to continuous improvement initiatives in a patient-safety- and operational-excellence-focused environment. This is a 100% onsite position in Madison, Wisconsin, working Wednesday through Saturday from 11:00 p.m. to 9:00 a.m. A $5,000 sign-on bonus is available.

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®.
• Apply cGMP principles and best practices to ensure compliant, high-quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations, with ability to learn new processes and techniques.
• Experience with deviation investigations, including corrective and preventive actions (CAPAs).
• Experience authoring and editing SOPs and related documentation under guidance.
• Ability to see, hear, read, and write clear English.
• Comply with EHS responsibilities.
• Frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching with hands and arms, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping.
• Frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Nice To Haves

• GMP experience in manufacturing or quality.

Responsibilities

• Facilitate the Rapid Response Team as deviations occur and document critical information to determine root cause.
• Review logbooks in a timely manner to ensure data complies with cGMP expectations and assist with tracking and monitoring open investigations.
• Participate in initiatives to improve process compliance culture, including cGMP understanding, self-audits, and CAPA programs.
• Participate in internal audits and assist in closing applicable findings.
• Identify and assist with employee training issues, instruction problems, or new educational needs related to employees or equipment.
• Inform personnel of communications, decisions, and policies affecting performance and GMP compliance.
• Support authoring Standard Operating Procedures for new processes, systems, or technologies, or when gaps are identified.
• Assist in identifying safety improvements and provide on-the-floor manufacturing support.
• Perform other duties as assigned.

Benefits

• $5,000 sign-on bonus available.
• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Community engagement and green initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED