Principal Scientist - Process Development, Upstream

Catalent•Madison, WI

2d•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 Principal Scientist - Process Development, Upstream is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for clinical trials. This role will lead and execute complex process development activities including seed train scale-up, bioreactor operations, and process optimization using Design of Experiments (DoE), while supporting tech transfer to manufacturing. The individual will operate as a technical lead across multiple projects, collaborating cross-functionally and with external clients to ensure robust, scalable processes and successful delivery across early-phase through late-stage development programs.

Requirements

Ph.D. in Biotechnology or related field with 8–10 years of laboratory experience, OR MS with 12+ years, OR BS with 15+ years of industry experience
Experience in development and implementation of upstream process development methodologies, including mammalian cell culture and bioreactor operations
Hands-on experience with process development, scale-up, and transfer of processes to cGMP manufacturing
Strong knowledge of Design of Experiments (DoE), process optimization, and process parameter definition
Experience working in a cGMP environment and applying good documentation practices (GDP)
Ability to independently design, execute, and analyze experiments, interpret complex data, and provide insight into potential issues and solutions
Ability to troubleshoot and problem solve complex process issues, analyze data, and initiate and execute corrective actions
Strong technical writing skills with experience authoring SOPs, batch records, protocols, and technical reports
Ability to lead multiple complex projects, communicate effectively with internal and external clients, and provide technical leadership and mentorship

Responsibilities

Lead the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures for transfer to cGMP manufacturing
Troubleshoot and problem solve process issues, initiate and execute corrective actions, and monitor outcomes to ensure successful project completion
Design and execute process development experiments including seed train scale-up, bioreactor inoculation, and production operations
Apply Design of Experiments (DoE) for clone screening, process optimization, and defining process parameters and operating conditions
Support tech transfer activities to manufacturing, ensuring processes are robust and can be successfully transferred to cGMP manufacturing
Lead multiple complex projects at a time and serve as a technical lead providing scientific consultation and direction
Analyze and interpret complex data, integrate experimental results with project objectives, and provide insight into potential issues and solutions
Collaborate with internal functional areas and external clients to communicate project status and ensure delivery of high-quality processes