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MSAT Research Associate

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Prokidney is seeking a Research Associate 2 for our MSAT Team. This role requires an understanding of biopharmaceutical processes and GMP compliance. In this role you will support manufacturing by troubleshooting potential issues, qualify materials, and provide data to support deviation investigations.

Responsibilities

  • Design and execute experiments to resolve issues observed in manufacturing processes for cell therapy. Analyze experimental data and present results in a clear and actionable manner to stake holders.
  • Support material qualification by assessing risks impacting product quality.
  • Maintain and update BOM (Bill of Materials) as related process changes are implemented.
  • Preparation and review of technical documentation, including batch records, SOPs (Standard Operating Procedures), and change controls.
  • Assist in training and coaching manufacturing staff, providing MSAT oversight and support within a cleanroom environment.
  • Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure the successful transfer of process into GMP clinical and commercial manufacturing.

Qualifications: 

  • 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 in execution and troubleshooting experiments, analyzing/ reporting/presenting 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, critical thinking, and the ability to collaborate with cross-functional teams. 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.
  • Must be comfortable handling human tissues.
  • There will be occasional weekend work.

 

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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