Cell Therapy Process Development Lead

ProKidney Corp.; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

ProKidney Corp. seeks a Cell Therapy Process Development Scientist to design and optimize manufacturing processes for the Rilparencel program, currently in phase 3 trials.

You will lead studies, apply advanced technologies, and coordinate with internal teams and external partners to transition processes from lab to clinical and commercial production. This role offers the opportunity to advance life-saving therapies and tackle complex bioprocessing challenges.

Qualifications

• PhD with 2+ years experience, MS with 8+ years, or BS with 12+ years in bioprocess or cell therapy process development.
• Hands-on experience with cell expansion, selection, and purification; proven tech transfer capabilities.
• Experience in QbD and DoE with statistical analysis.
• Knowledge of flow cytometry, PCR, ELISA, and cell counting for therapy characterization.
• Excellent problem-solving and ability to communicate across disciplines.
• Self-motivated, detail-oriented, and able to manage multiple priorities.
• Strong interpersonal skills and cross-functional teamwork.

Responsibilities

• Design and execute studies to develop and optimize cell therapy manufacturing processes, including expansion, selection, purification, formulation and cryopreservation.
• Design and implement process improvements to reduce cost, improve efficiency, and enhance product quality while ensuring regulatory compliance.
• Work closely with Manufacturing to ensure smooth technology transfer and GMP manufacturing runs.
• Perform process risk assessment using FMEA and design experiments to characterize process parameters.
• Participate in project teams and support transition from pre-clinical to clinical and commercial manufacturing.
• Stay current with trends, technologies, and regulatory developments in cell therapy.
• Contribute to publications, presentations, and internal knowledge sharing.

Skills

Bioprocessing

Cell therapy

Problem solving

Communication

Project management

Detail oriented

Team collaboration

Education

PhD in Bioprocessing

MS in related field

BS in related field

Tools

JMP

DoE

Job description

ProKidney Corp. seeks a Cell Therapy Process Development Scientist to design and optimize manufacturing processes for the Rilparencel program, currently in phase 3 trials.

You will lead studies, apply advanced technologies, and coordinate with internal teams and external partners to transition processes from lab to clinical and commercial production. This role offers the opportunity to advance life-saving therapies and tackle complex bioprocessing challenges.