Director - Process Development, Upstream

Director, Upstream Process Development

Position Summary

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.

Our new, state-of-the-art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers’ growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

The Director of Upstream Process Development will lead the upstream process development team in designing, optimizing, and scaling up robust, efficient, and reproducible cell culture processes for biologics manufacturing. This role is critical to ensuring the successful development and tech transfer of processes for clinical and commercial production, meeting client expectations, regulatory requirements, and internal quality standards. The Director of Upstream Process Development will collaborate cross-functionally with downstream process development, analytical development, manufacturing, quality, and client-facing teams to deliver high-quality biologics within timelines and budgets.

The Upstream Process Development team 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 human clinical trials. The unit operations, process parameters, and process information to be developed, executed, and transferred include, but are not limited to, seed train scale-up and production bioreactor inoculation specifications and setpoints, specific process parameter monitoring and data collection requirements, media and feeding strategies, and harvest criteria. The process development experiments involved with this research range from high-throughput, Design of Experiment (DoE) formats for clone screening and process optimization to pilot-scale Single Use Bioreactor (SUB) toxicology or engineering non-GMP runs to support cGMP manufacturing. To support this research, the team members also contribute to a variety of lab support areas including equipment maintenance, raw materials management, and investigation support; the project experiment designs and results are routinely communicated with external clients and internal functional areas to ensure the quality of the final process.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

• Lead, mentor, and develop a team, which may include principal level scientists, scientists and engineers specializing in upstream process development, fostering a culture of innovation, collaboration, and accountability. 

• Set strategic goals for the upstream process development group, aligning with company objectives and client deliverables; Manage resource allocation, project prioritization, and team capacity to meet multiple concurrent client projects.

• Direct the development of scalable processes to support optimal expression, purification, and product quality attributes for both antibodies, recombinant proteins, or other biomolecules.

• Oversee the design and development of upstream processes for mammalian cell lines (e.g., CHO, HEK293) used in biologics production.

• Optimize cell culture conditions, bioreactor operations, and feeding strategies to maximize product yield, quality, and consistency while minimizing costs.

• Understand and be able to implement advanced technologies such as perfusion, fed-batch, or continuous processing to enhance process efficiency and scalability.

• Utilize Design of Experiments (DoE), high-throughput screening, and process analytical technologies (PAT) to drive data-driven process optimization.

• Lead scale-up activities from laboratory-scale bioreacto