Scientist I - Quality Control, Data Review

Catalent • Madison, WI

1d • 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, Data Review to join our team. In this role, you will execute and document cGMP Quality Control testing with accuracy and compliance. You will operate basic and moderately complex equipment, assist in authoring technical documents, and review analytical data for consistency. You will also support data entry, lab housekeeping, and preventive maintenance while contributing to team meetings and training sessions.

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
• Strong understanding of analytical chemistry and simple and moderately complex lab equipment
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience
• Knowledge of cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP)
• Experience following standard operating procedures (SOP)
• General laboratory equipment experience, including micropipettes

Nice To Haves

• Experience with EMPOWER system for High-Performance Liquid Chromatography (HPLC)
• Knowledge of Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), and Reverse Phase HPLC (RP-HPLC)
• Background in Enzyme-Linked Immunosorbent Assay (ELISA) and plate-based assays
• Experience with compendial methods, appearance, pH, concentration, and osmolality testing

Responsibilities

• Review a variety of different tests
• Read and update standard operating procedures (SOPs)
• Perform monthly routine checks of logbooks in the lab
• Ensure adherence to protocols and methods
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Review analytical and microbiological data
• All 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
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level