Senior Scientist I - Quality Control - Data Review
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 Senior Scientist I - Quality Control - Data Review to join our team. In this role, you will execute and document cGMP Quality Control testing with precision. You will operate equipment, review analytical data, and ensure compliance with SOPs. You will also contribute to technical documentation and support laboratory operations in a collaborative environment.
Requirements
- Ph.D. in Biology, Biotechnology, Chemistry or related life sciences field OR Master’s degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 4 years of industry experience OR Bachelor’s degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 6 years of industry experience OR Associate degree in Biology, Biotechnology, Chemistry or related life sciences field with a minimum of 10 years of industry experience OR High School Diploma or equivalent with a minimum of 11 years of industry experience
- Intermediate to advanced proficiency in Microsoft Office preferred
- Familiarity with EMPOWER software preferred
Nice To Haves
- Experience with EMPOWER system used for High-Performance Liquid Chromatography (HPLC)
- Strong background in Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), and Reverse Phase High-Performance Liquid Chromatography (RP-HPLC)
- Experience with Enzyme-Linked Immunosorbent Assay (ELISA) and plate-based assays
- Knowledge of compendial methods, appearance, pH, concentration, and osmolality
Responsibilities
- Review a variety of different tests
- Review and update Standard Operating Procedures (SOPs)
- Perform monthly routine checks of logbooks within the lab
- Ensure adherence to protocols and methods
- Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Review analytical and microbiology data
- Assist with training of junior staff
- Help coordinate day-to-day tasks in the supervisor’s absence
- All other duties as assigned.
Benefits
- Competitive paid time off plus 8 paid holidays
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
