Scientist, Process Development

ProKidney Corp.; Winston-Salem (NC); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Bioprocess development

Cell therapy

Technology transfer

DoE (Design of Experiments)

QbD

Flow cytometry

PCR

ELISA

Statistical analysis

Communication skills

Formação académica

PhD with 2+ years experience

MS with 8+ years experience

BS with 12+ years experience

Ferramentas

JMP

Descrição da oferta de emprego

Winston-Salem, North Carolina, United States

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 shape 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 assess process parameters 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.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.