Manager, MS&T

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 highly skilled and experienced MSAT Manager to provide expert technical support for our cell therapy clinical manufacturing operations. This role requires a deep understanding of biopharmaceutical processes and a proven track record in GMP compliance, process transfer, and material qualification. Initially, the MSAT Manager will work as an individual contributor with the expectation to build and lead a team in the future. The MSAT Manager will report directly to the Senior Director of MSAT.

Responsibilities:

• Provide expert technical support to resolve manufacturing issues and recommend improvements for safety and GMP compliance.
• Lead and manage complex deviation investigations, partnering with relevant teams to identify root causes and develop effective CAPAs.
• Oversee large-scale change controls, ensuring that change actions are completed within agreed timelines.
• Own the Bill of Materials (BoM) for manufacturing.
• Act as a key member of the material review board, supporting material qualification and assessing risks impacting product quality.
• Serve as a subject matter expert (SME) during internal and external audits.
• Author, review, and approve key documents, including SOPs, MBRs, URSs, and study reports.
• Assist in training and coaching manufacturing staff, providing MSAT oversight and support within the cleanroom environment.
• Ensure compliance with all regulatory and scientific requirements relevant to clinical manufacturing.
• Contribute expert input into process design, comparability studies, and change control systems.
• Support regulatory applications and amendments with process-related information.
• Collaborate with vendors on outsourced studies and evaluate new technologies.

Qualifications:

• Bachelor’s degree in Chemical/Biological Sciences, Chemical/Biochemical/Biomedical Engineering, or a related field. Advanced degrees (Master’s or PhD) are advantageous.
• 10+ years of biopharmaceutical industry experience with a Bachelor’s degree, 8+ years with a Master’s degree, or 5+ years with a PhD.
• Extensive experience in conducting deviation investigations using tools such as Fishbone Diagrams, 5 Whys, GEMBA, and Risk Analysis.
• In-depth knowledge of GMP requirements and cleanroom classifications.
• Strong expertise in aseptic techniques and cell culture; experience with cell and gene therapies is a plus.
• Understanding of quality attributes of materials used in GMP manufacturing.
• Proven ability to lead matrix teams, manage projects, and ensure timely completion of complex tasks.
• Experience in authoring and reviewing SOPs, MBRs, deviation investigations, change controls, and qualification reports.
• Ability to make decisions that balance speed, quality, and risk.
• Knowledge of basic statistical analysis.
• Excellent communication skills, with the ability to articulate ideas clearly and collaborate effectively with others.
• Adaptability to changing priorities, timelines, and resource availability.

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.