Associate Lead I - Biomanufacturing, Compliance
About The Position
The Associate Lead I - Biomanufacturing, Compliance supports cGMP manufacturing operations at Catalent’s Madison, Wisconsin biologics development and manufacturing site. The role helps ensure compliance with Standard Operating Procedures, regulatory requirements, and client requirements, while maintaining quality standards and contributing to continuous improvement initiatives. It is an onsite role on a Wednesday–Saturday, 11:00 p.m.–9:00 a.m. shift, with a $5,000 sign-on bonus available. Catalent’s Madison site is a GMP facility supporting customers from research through early- and mid-stage clinical production. It specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, using flexible single-use systems. Manufacturing scales range from 50 to 4,000 liters for clinical production. The site is home to Catalent’s GPEx® and GPEx® Lightning technologies.
Requirements
- High school diploma or GED and at least 4 years of related experience; or an Associate’s degree in a STEM field and 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®.
- 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 (CAPAs).
- Experience authoring and editing SOPs and related documentation under guidance.
- Ability to see, hear, read, and write clear English.
- Ability to meet the stated physical requirements, including frequent lifting or moving up to 10 pounds and occasional lifting or moving up to 50 pounds.
- Compliance with EHS responsibilities.
Nice To Haves
- GMP experience in manufacturing or quality.
Responsibilities
- Facilitate Rapid Response Team activity as deviations occur and document critical information to determine root cause.
- Review logbooks promptly to ensure data meets cGMP expectations and assist with tracking and monitoring open investigations.
- Participate in initiatives that improve process compliance culture, including cGMP understanding, self-audits, and CAPA programs.
- Participate in internal audits and assist with closing applicable findings.
- Identify and assist with training issues, instructional problems, and new educational needs for employees or equipment.
- Communicate information, decisions, and policies affecting employee performance and GMP compliance.
- Support authoring Standard Operating Procedures for new processes, systems, or technologies, and when gaps are identified.
- Assist in identifying safety improvements and provide on-the-floor manufacturing 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.
- $5,000 sign-on bonus available.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
