Lead - Biomanufacturing Compliance - Investigator, Deviations
About The Position
Catalent’s Madison, Wisconsin site is a biologics development and manufacturing facility supporting research through early- and mid-stage clinical production. The facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, using flexible single-use systems. It supports clinical manufacturing at scales from 50 to 4,000 liters and houses Catalent’s GPEx® and GPEx® Lightning technologies. The Lead - Biomanufacturing Compliance - Investigator, Deviations authors and revises deviation records and related cGMP documents, ensuring they are completed accurately and on time. The role collaborates with manufacturing and quality systems, supports audits, and contributes to compliance culture, inspection readiness, and continuous improvement. The position is based in Madison, Wisconsin, is 100% onsite, and has Monday-Friday core hours of 9 a.m. to 4 p.m.
Requirements
- High school diploma or GED and at least 7 years of related experience; or an Associate’s degree in a STEM field and at least 6 years of related experience.
- Alternatively, 3 or more years of experience with a Bachelor’s degree in a STEM-related field, or an MS/PhD in a technical discipline without formal experience.
- Experience writing deviations and conducting Root Cause Analysis and implementing Corrective and Preventive Actions.
- Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
- Ability to apply cGMP principles and best practices to ensure compliant, high-quality execution of procedures.
- 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.
- Experience authoring and editing Standard Operating Procedures and related documentation.
- Ability to see, hear, read, and write clear English.
- Ability to perform the listed physical activities and comply with Environmental Health and Safety responsibilities.
Nice To Haves
- Experience in large-scale upstream or downstream manufacturing of biological drug products in a GMP environment.
Responsibilities
- Author and revise complex deviation records, preventive actions, and other related cGMP documents in a timely manner.
- Apply working knowledge of upstream and downstream operations, materials management, production facilities, systems, and technologies.
- Track and monitor open investigations and provide timely, accurate status information.
- Lead initiatives to improve process compliance culture, including ongoing cGMP understanding and application.
- Lead inspection-readiness activities and teams.
- Write and revise Standard Operating Procedures and proactively identify gaps.
- Support internal and client audits regarding deviation and Corrective and Preventive Action status.
- Exhibit professional behavior with internal and external associates in accordance with company policies and practices.
- Participate regularly in team meetings for biomanufacturing compliance support.
- Perform other duties as assigned.
Benefits
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team.
- Competitive paid time off and 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
