Associate Lead I - Biomanufacturing, Compliance

Catalent Pharma Solutions • Madison, WI

2d • Onsite

About The Position

The Associate Lead I for Biomanufacturing Compliance helps drive the end-to-end execution of clinical and commercial production in a cGMP environment, delivering high-quality biologics in alignment with regulatory and client requirements. The team’s capabilities span solution preparation, cell banking, upstream and downstream processing, mRNA and molecular therapeutics, and small-scale fill/finish. Operating through integrated Process Execution and Process Compliance teams, Manufacturing ensures safe, right-first-time batch delivery while embedding continuous improvement to optimize processes, increase efficiency, and expand capacity. This collaborative model enables strong on-the-floor support, rapid issue resolution, and consistent adherence to compliance standards which creates a high-impact, growth-oriented environment for professionals in biomanufacturing.

Requirements

• Must have a minimum of High School Diploma/GED with at least 4+ years of related experience or an Associate’s degree in STEM with 1+ years of related experience.
• No experience required with a Bachelor’s degree in STEM related field.
• Related experience encompasses proficiency in Microsoft Office and capable of learning and using quality and scientific systems (e.g., TrackWise®, ComplianceWire®, JD Edwards®, 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.

Responsibilities

• Facilitate Rapid Response Team as deviations occur, documenting critical information to determine true root cause.
• Provide timely review of logbooks as needed to ensure data complies with cGMP expectations.
• Actively engage in Inspection Readiness activities and teams.
• Assist to track/monitor and provide timely, accurate information regarding status of open investigations.
• Participate in initiatives to improve process compliance culture, including on-going cGMP understanding and application, including 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 regarding specific employees or groups or equipment.
• Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results as it relates to GMP compliance.
• Supports authoring Standard Operating Procedures (SOPs) for new processes, systems or technologies or when gaps are identified.
• Assists in identifying improvements for safety and provides on the floor manufacturing support.
• 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 within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement

What This Job Offers

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