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

Proficiency in Microsoft Office
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.