Associate Lead I - Biomanufacturing Compliance, Lead Investigator
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, with production scales from 50 to 4,000 liters for clinical manufacturing. The Associate Lead I - Biomanufacturing Compliance, Lead Investigator authors and revises deviation records, preventive actions, and related cGMP documentation, ensuring work is completed accurately and on time. The role collaborates with manufacturing and quality systems, tracks investigations, supports audits and inspection readiness, and contributes to process-compliance and continuous-improvement initiatives. The position is 100% onsite in Madison, Wisconsin, with Monday–Friday core hours from 9 a.m. to 4 p.m.
Requirements
- High school diploma or GED and at least 4 years of related experience; or an Associate’s degree in a STEM field and at least 1 year of related experience; or a bachelor’s degree in a STEM-related field, with no experience required.
- 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, and 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 under guidance.
- Ability to see, hear, read, and write clear English.
- Ability to perform 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; frequent lifting or moving up to 10 pounds and occasional lifting or moving up to 50 pounds.
Nice To Haves
- Experience in large-scale upstream or downstream manufacturing of biological drug products in a GMP environment.
Responsibilities
- Author and revise deviation records, preventive actions, and related cGMP documents under minimal supervision, completing them accurately and on time.
- Develop familiarity with upstream and downstream operations, materials management, the production facility, systems, and technologies to perform responsibilities accurately.
- Track and monitor open investigations and provide timely, accurate status updates.
- Contribute to initiatives that improve process-compliance culture and the ongoing understanding and application of cGMP.
- Participate in inspection-readiness activities and teams.
- Provide guidance on writing and revising Standard Operating Procedures when gaps are identified.
- Assist with internal and client audits as needed.
- Maintain professional conduct with internal and external associates and follow company policies and practices.
- Participate in team meetings.
- Perform other duties as assigned.
- Comply with Environmental Health and Safety responsibilities.
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
Mid Level
