Manager, Training Manufacturing

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.

Position Summary:
The Manufacturing Training Manager is responsible for ensuring that all team members within the manufacturing team are comprehensively trained in ProKidney’s manufacturing process as well as Good Manufacturing Practices (GMP) and compliance standards, in alignment with QA. This position combines expertise in training with a focus on manufacturing, aseptic and GMP compliance principles, acting as a business partner to manufacturing to help meet organizational goals. As a critical team member, this manager will develop, implement, and oversee technical training programs, ensuring a continuous state of readiness for production This role also leads strategic training initiatives, supports team development, and upholds a culture of excellence and compliance within manufacturing.

Essential Duties & Responsibilities:

Manufacturing Training Program Development & Delivery

• Design and deliver specialized GMP manufacturing training modules and technical courses, applying adult learning principles and instructional design.
• Collaborate with Manufacturing and support teams to create effective learning solutions that align with business objectives.
• Serve as the primary point of contact for audit responses related to training, representing Manufacturing Training & Compliance during inspections, audits, and emergent issues.
• Lead strategic training projects, consult on curriculum development for new or evolving roles, and oversee the continuous improvement of training programs.
• Coach and mentor team members in adherence to GMP standards, promoting a culture of quality and compliance throughout the organization.

Aseptic & Manufacturing Compliance Oversight

• Oversee aseptic processing areas, ensuring all personnel entering are properly trained, qualified, and in compliance with GMP standards.
• Track and maintain records of qualifications, including aseptic process simulations, gowning qualifications, and technical training for new and existing employees.

• Conduct regular audits of manufacturing training sessions and aseptic processes to identify additional training needs and areas for improvement.

Supervisory & Leadership Responsibilities

• Support the Manufacturing team by supervising day-to-day operations, including assigning duties, managing shift exchanges, and attending team meetings.
• Coach, develop, and evaluate team members through regular performance reviews, career planning, and one-on-one mentorship.
• Oversee recruiting, hiring, onboarding, performance management, and career progression for operators as needed, ensuring team readiness for GMP compliance.
• Maintain individual training plans for team members, ensuring they are up-to-date and fully compliant with regulatory standards.

Training Administration & Content Development

• Develop and coordinate training schedules, ensuring timely delivery of on-the-job (OJT) training and other GMP courses.
• Create training materials such as job aids, reference guides, and classroom content with input from Subject Matter Experts (SMEs).
• Develop e-learning content and manage training uploads into the Learning Management System (LMS).
• Handle administrative tasks, including shift exchanges, meeting participation, email communication, and involvement in continuous improvement initiatives.
• Demonstrate strong technical writing skills by creating SOPs, documenting deviations, and revising training documents as required.

Continuous Improvement & Compliance Support

• Work closely with the compliance team to identify, prioritize, and address training goals, especially for new documentation or revisions.
• Regularly review and refine training plans for new hires and ongoing development to meet evolving regulatory and operational requirements.
• Actively observe manufacturing processes to identify training gaps, providing recommendations for improvement to ensure adherence to GMP and aseptic standards.

Minimum Qualifications:

Education/Training: Qualifications:

• A. or B.S. in Life Sciences or Educational Development
• High School Diploma or Equivalent may be considered with relevant experience.
• Five or more years relevant training/education and delivery of technical topics experience in Cell Therapy, FDA-regulated industry, or pharmaceutical preferred.

• Proven experience in a GMP-regulated environment with a strong understanding of aseptic processes.
• Exceptional skills in coaching, training development, and adult learning principles.
• Demonstrated technical writing abilities for SOP creation, deviation management, and compliance documentation.
• Strong organizational skills, with the ability to manage and prioritize multiple training and supervisory responsibilities.
• Excellent communication skills, capable of fostering a quality-driven mindset across diverse teams.

• Instructional Design education or experience preferred.

• Experience with curricula development preferred.

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.