Scientist I - Quality Control- Microbiology

Catalent Pharma Solutions•Madison, WI

2d•Onsite

About The Position

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 a Scientist I - Quality Control- Microbiology to join our team. In this role, you will perform cGMP Quality Control testing and ensure accurate documentation. You will operate laboratory equipment, assist in preparing technical documents, and maintain compliance with established procedures. This position involves active participation in team activities and maintaining a clean and organized laboratory environment.

Requirements

Master’s Degree in Biology, Biotechnology, Chemistry or related life sciences field.
Bachelor’s Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 3 years of industry experience.
Associate Degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience.
High School Diploma or equivalent with a minimum of 7 years of industry experience.
Experience with analytical chemistry and simple and moderately complex lab equipment.
Familiarity with clean room procedures, aseptic technique, and general lab equipment.
Knowledge of cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
Experience following Standard Operating Procedures (SOPs).
General laboratory equipment experience, including micropipettes.

Nice To Haves

Experience with High-Performance Liquid Chromatography (HPLC) and Enzyme-Linked Immunosorbent Assay (ELISA).

Responsibilities

Independently execute and properly document cGMP Quality Control testing.
Operate basic and moderately complex cGMP Quality Control equipment.
Assist in authoring technical documents such as Standard Operating Procedures (SOPs) and reports.
Perform self-review of analytical data for accuracy and consistency with SOPs.
Enter data into Laboratory Information Management System (LIMS) or laboratory reports.
Perform general lab housekeeping in adherence to 5S standards.
Initiate and assist with records in Trackwise.
Accurately complete routine and preventive maintenance on basic to moderately complex equipment.
Actively participate in team meetings and training sessions.
Perform other duties as assigned.