Cell Therapy Process Development Associate (Contractor)

ProKidney; Fort Worth (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

ProKidney is seeking an experienced research associate to join our cell therapy process development team in Fort Worth, TX. The role focuses on advancing manufacturing processes for cell therapies, including experimentation, data analysis, and documentation.

You will work closely with manufacturing science, analytical development, quality control, and QA to ensure timely reporting, regulatory alignment, and continuous improvement.

Qualifications

• Bachelor’s degree or higher in a relevant science or engineering field.
• 2+ years of cell therapy or upstream biopharmaceutical development experience.
• Experience with aseptic techniques and cell culture in lab settings.
• Ability to work across cross‑functional teams and manage competing priorities.
• Understanding GMP/GLP and regulatory requirements for cell-based therapies.

Responsibilities

• Execute experiments to optimize cell therapy manufacturing processes, including media preparation, cell expansion, harvest, and product formulation.
• Provide feedback on new techniques and technologies and support process improvements.
• Work with manufacturing science, analytical development, quality control, and QA to summarize findings and report timelines.
• Support regulatory filings and audits; prepare development reports and SOPs.
• Identify risks in process development and implement mitigation strategies to advance programs.
• Ensure adherence to GMP and regulatory standards throughout development activities.
• Assist in preparation and review of batch records and change controls.

Skills

Cell culture

Team collaboration

Data analysis

Technical writing

Problem solving

Education

Bachelor’s or Master’s in a relevant field

Job description

ProKidney is seeking an experienced research associate to join our cell therapy process development team in Fort Worth, TX. The role focuses on advancing manufacturing processes for cell therapies, including experimentation, data analysis, and documentation.

You will work closely with manufacturing science, analytical development, quality control, and QA to ensure timely reporting, regulatory alignment, and continuous improvement.