Cell Therapy Process Development Scientist

ProKidney Corp.; Winston-Salem (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC is seeking a Cell Therapy Process Development Scientist to develop and optimize manufacturing processes for Rilparencel, currently in phase 3.

You will design studies, implement scalable technologies, and collaborate with internal teams and external partners to move processes from lab to clinical and commercial production. The role requires advanced degrees with extensive bioprocess or cell therapy experience, hands-on cell expansion and purification, QbD/DoE

Qualifications

• Degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Cell Biology, Bioengineering, or related discipline.
• PhD with 2+ years, MS with 8+ years, or BS with 12+ years in bioprocess or cell therapy development.
• Hands-on experience with cell expansion, selection and purification; track record of technology transfer of manufacturing processes.
• Experience in QbD and process characterization; use of DoE and statistical analysis.
• Knowledge of flow cytometry, PCR, ELISA, cell counting and related assays for cell therapy characterization.
• Excellent problem-solving skills to troubleshoot complex process-related challenges.
• Strong communication to explain technical information to both technical and non-technical stakeholders.
• Self-motivated, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Strong interpersonal skills for cross-functional collaboration.

Responsibilities

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

Skills

Bioprocess development

Cell therapy

Technology transfer

DoE (Design of Experiments)

QbD

Flow cytometry

PCR

ELISA

Statistical analysis

Communication skills

Education

PhD with 2+ years experience

MS with 8+ years experience

BS with 12+ years experience

Tools

JMP

Job description

ProKidney Corp. in Winston-Salem, NC is seeking a Cell Therapy Process Development Scientist to develop and optimize manufacturing processes for Rilparencel, currently in phase 3.

You will design studies, implement scalable technologies, and collaborate with internal teams and external partners to move processes from lab to clinical and commercial production. The role requires advanced degrees with extensive bioprocess or cell therapy experience, hands-on cell expansion and purification, QbD/DoE