Associate Lead – Biomanufacturing Compliance, Investigator - Deviations

About Site

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑and‑mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.

Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑and‑mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.

Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

We have an opportunity for an Associate Lead I – Biomanufacturing Compliance, Investigator – Deviations to join our team. In this role, you will be responsible for authoring and revising deviation records and related cGMP documents while ensuring timely and accurate completion. You will work closely with various manufacturing and quality systems, support audits, and contribute to a strong compliance culture.

This position offers the chance to actively participate in inspection readiness and continuous improvement initiatives.

Shift: Mon-Friday, core hours 9am-4pm

Location:

Madison, WI

100% Onsite

• Author and revise deviation records, preventative actions, and related cGMP documents under minimal supervision in a timely manner.
• Develop familiarity with upstream, downstream, materials management, production facility, systems, and technologies to ensure accurate completion of responsibilities.
• Track and monitor open investigations, providing timely and accurate status updates.
• Engage in initiatives to improve process compliance culture, including ongoing cGMP understanding and application.
• Actively participate in Inspection Readiness activities and teams.
• Provide guidance to write and revise Standard Operating Procedures when gaps are identified.
• Assist in supporting internal and client audits as needed.
• Exhibit professional behavior with internal and external associates, reflecting positively on the company and aligning with company policies and practices.
• Participate in team meetings.
• Perform other duties as assigned.

• High School Diploma or GED with at…