The Cell Therapy Process Development Scientist will play a critical role in the development and optimization of robust and reproducible processes for the manufacturing of ProKidney’s cell therapy product, Rilparencel, which is in phase three clinical trial. The process development scientist will design and execute studies and implementation of cutting-edge technologies for commercial production. You will work in a fast-paced, highly collaborative environment, engaging with various internal teams, external partners, and key stakeholders to ensure the seamless transition of processes from the laboratory to clinical and, eventually, commercial production.

This role offers an exciting opportunity to make a direct impact on the development of life-saving therapies while applying your scientific expertise to solve complex challenges in cell therapy.

Key Responsibilities

• Design and execute studies to develop and optimize cell therapy manufacturing processes, including cell expansion, selection, purification, formulation, and cryopreservation. Analyze and interpret experiment results. Write and review study reports.
• Design and implement process improvements that reduce cost, improve efficiency, and enhance product quality, while maintaining compliance with regulatory requirements.
• Work closely with Manufacturing teams to ensure smooth technology transfer and the successful execution of GMP manufacturing runs, ensuring process robustness and troubleshooting any issues that arise.
• Perform process risk assessment using tools including FMEA. Design and execute experimental plans to characterize and validate critical process parameters (CPPs) of cell therapy products.
• Participate in project teams and contribute technical expertise to support the transition from pre-clinical to clinical and commercial manufacturing.
• Stay current with the latest trends, technologies, and regulatory developments in the cell therapy field.
• Contribute to scientific publications, presentations, and internal knowledge sharing.

Qualifications

• Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Cell Biology, Bioengineering, or a related discipline.
• PhD with 2+ years experience, MS with 8+ years experience, or BS with 12+ years experience in bioprocess or cell therapy process development.
• Extensive hands-on experience with cell expansion, cell selection and cell purification. Proven track record of contributing to successful technology transfer of manufacturing processes.
• Experience in QbD and process characterization including the use of DoE (Design of Experiments) and statistical analysis.
• Knowledge of analytical methods such as flow cytometry, PCR, ELISA, cell counting, and other assays for cell therapy characterization.
• Excellent problem-solving skills and the ability to troubleshoot complex process-related challenges.
• Strong communication skills, with the ability to articulate complex technical information to both technical and non-technical stakeholders.
• Self-motivated, detail-oriented, and able to manage multiple priorities effectively in a fast-paced, dynamic environment.
• Strong interpersonal skills and the ability to work collaboratively in a cross-functional, multidisciplinary team.

Preferred Qualifications

• Experience in preparing regulatory filings.
• Familiarity with data analysis software (e.g., JMP).
• Experience in GMP regulations.