Cell Therapy Process Development Associate - Contractor

ProKidney; Winston-Salem (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

ProKidney is seeking an experienced Research Associate 1 to join the Process Development Contractor team in Winston-Salem, NC. The role centers on advancing cell therapy manufacturing processes, including media preparation, cell expansion, and product formulation, while collaborating with cross-functional teams to deliver robust process improvements.

The ideal candidate holds a Bachelor’s or Master’s in a related field and has 2+ years in cell therapy or upstream biopharmaceutical development,

Qualifications

• Bachelor’s or Master’s degree in chemical engineering, biomedical engineering, biochemistry, cell biology, biotechnology, or a similar field.
• 2+ years of experience in cell therapy and/or biopharmaceutical upstream process development; aseptic techniques required.
• Ability to work in cross-functional teams, meet deadlines, and manage multiple projects.
• Strong problem-solving, critical thinking, and technical writing skills, with GMP/GLP awareness.

Responsibilities

• Execute experiments to optimize and improve processes for cell therapy manufacturing, including media prep, cell expansion and harvest, and product formulation.
• Analyze data and present results clearly to stakeholders.
• Provide technical feedback for new techniques and technologies; support troubleshooting and process improvement.
• Collaborate with manufacturing science, analytical development, quality control, and QA to summarize and report findings.
• Support characterization of cell therapy processes in compliance with regulatory standards.
• Ensure activities adhere to GMP and regulatory standards; assist with regulatory filings and audits.
• Prepare and review technical documentation such as process development reports, batch records, SOPs, and change controls.
• Identify potential risks in process development and manufacturing and implement mitigation strategies.

Skills

Cell therapy

Upstream process development

Process characterization

Cross-functional teamwork

Regulatory awareness

Education

Bachelor’s or Master’s degree in chemical/biomedical fields

Job description

ProKidney is seeking an experienced Research Associate 1 to join the Process Development Contractor team in Winston-Salem, NC. The role centers on advancing cell therapy manufacturing processes, including media preparation, cell expansion, and product formulation, while collaborating with cross-functional teams to deliver robust process improvements.

The ideal candidate holds a Bachelor’s or Master’s in a related field and has 2+ years in cell therapy or upstream biopharmaceutical development,