Associate Scientist - Process Development, Downstream

Catalent•Madison, WI

1d•Onsite

About The Position

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Associate Scientist – Process Development is responsible for supporting the development and optimization of biologic manufacturing processes, including upstream cell culture and downstream purification activities. This role executes laboratory experiments such as seed train scale-up, bioreactor operations, and protein purification while applying standard statistical methods to analyze data and improve process performance. The Associate Scientist will maintain accurate documentation in accordance with SOPs and GMP practices, support tech transfer to manufacturing, and collaborate cross-functionally with internal teams and external clients to ensure successful project delivery in a fast-paced, client-driven environment.

Requirements

Bachelor’s degree in a STEM discipline with 1–3 years of related experience
Equivalent technical competency may also be demonstrated through completion of a bachelor’s degree in Chemical Engineering or a closely related discipline with relevant laboratory, research, or co-op experience
Ability to execute laboratory procedures and experiments of moderate complexity with minimal guidance
Hands-on experience or exposure to cell culture, bioreactors, or downstream purification (chromatography, TFF, AKTA)
Experience with data analysis and statistical methods (e.g., DoE) and ability to interpret results
Experience working within GMP/regulatory environments, including SOPs, GDP, and batch record (BPR) documentation
Ability to identify out-of-spec data, troubleshoot issues, and support investigations
Strong organization, communication, and ability to manage multiple priorities in a fast-paced environment
Experience supporting lab operations (equipment maintenance, cleaning, stocking, 5S) and working cross-functionally

Responsibilities

Execute laboratory experiments supporting upstream process development, including cell bank vial thaws, seed train scale-up, and bioreactor operations
Perform cell culture analytical methods and apply platform processes with moderate modification to optimize productivity and product quality
Analyze experimental data using standard statistical methods, including Design of Experiments (DoE)
Support downstream purification activities, including chromatography (AKTA), filtration, and tangential flow filtration
Maintain accurate documentation and batch production records (BPRs) in accordance with SOPs and GDP requirements
Collaborate cross-functionally and communicate results with internal teams and external clients to meet project timelines
Support lab operations, including equipment maintenance, cleaning, material stocking, and 5S organization
Contribute to process development, optimization, and continuous improvement initiatives across client and internal programs