Process Development Research Associate 2

ProKidney • Winston-Salem, NC

430d

About The Position

The Research Associate 2 position at ProKidney focuses on the development and optimization of cell therapy manufacturing processes aimed at treating chronic kidney disease (CKD). The role involves leading experiments, analyzing data, and collaborating with cross-functional teams to ensure compliance with regulatory standards and successful technology transfer into clinical and commercial manufacturing.

Requirements

• Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or a related field.
• 3 plus years of experience in cell therapy and/or biopharmaceutical process development.
• Ability to execute and troubleshoot experiments, analyze, report, and present data.
• Experience in aseptic techniques is essential.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.
• Strong problem-solving abilities and critical thinking skills.
• Strong verbal and written communication skills, including technical writing.
• Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies.
• Experience with regulatory submissions and support for inspections is a plus.
• Demonstrated troubleshooting and problem-solving skills.
• Understanding of basic statistics and working knowledge of statistical software (e.g. JMP).
• Comfortable handling human tissues.

Nice To Haves

• Experience with regulatory submissions and support for inspections.

Responsibilities

• Design and execute experiments to optimize and improve processes for cell therapy manufacturing, including media preparation, cell expansion, and product formulation.
• Analyze experimental data and present results to stakeholders in a clear and actionable manner.
• Provide technical expertise in the development and implementation of new techniques and technologies.
• Support troubleshooting and process improvement initiatives.
• Collaborate with Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure successful process transfer into GMP clinical and commercial manufacturing.
• Support characterization and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards.
• Conduct process performance qualification (PPQ) studies and support clinical trial material production.
• Ensure all process development activities adhere to GMP and applicable regulatory standards.
• Support regulatory filings and audits as needed.
• Prepare and review technical documentation, including process development reports, batch records, SOPs, and change controls.
• Identify potential risks in process development and manufacturing and implement strategies for mitigation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree