Senior Associate Scientist, Downstream Process Development

About the role

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. The Product Development network supports development of biologic modalities (mAbs, novel protein modalities, mRNA, exosomes, enzymes, viral proteins) from initial early phase through late‑stage projects to PPQ and launch. The Development team designs and conducts process, analytical, and formulation work. For scale‑up, the Upstream (US) based teams in Manufacturing Science and Technology (MS&T) support tech transfer for Downstream (DS) and fill finish (Catalent or client developed processes). The Senior Associate Scientist will perform a variety of laboratory procedures in Downstream Process Development, performing daily work assignments accurately, timely, and safely, independently evaluating, selecting, and applying standardized scientific techniques to assignments of moderate complexity, and seeking continual improvement of work practices from experience with moderate‑sized projects while developing extensions to existing methods and protocols.

Responsibilities

• Execute and support downstream process development activities, including protein purification, chromatography, filtration, clarification, column packing, and tangential flow filtration at small and pilot scale.
• Independently design, execute, and analyze experiments, including Design of Experiments (DOE), process characterization, and scale‑down model qualification.
• Apply advanced knowledge of protein purification techniques and analytical methods, including HPLC, ELISA, and gel electrophoresis.
• Analyze and interpret experimental and manufacturing data, perform process trending and statistical analysis, and provide recommendations based on results.
• Author and review technical documentation, including protocols, reports, batch records, and laboratory documentation in compliance with