Manufacturing Support Supervisor

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 Support Supervisor is responsible for overseeing day-to-day operations of the manufacturing support team, ensuring adherence to cGMP guidelines, and coordinating key production activities such as media preparation, material kitting, and GMP cleaning. This role involves supervising personnel, managing schedules, ensuring safety and quality compliance, and collaborating with cross-functional teams to meet production targets.

Essential Duties & Responsibilities:

• Supervision & Leadership:
• Supervise and manage the manufacturing support team to ensure efficient production processes.
• Oversee day-to-day operations, including media preparation, material kitting, GMP cleaning, and other support tasks.
• Lead, coach, and develop team members through regular performance reviews, training, and career development activities.
• Foster a culture of teamwork, accountability, and continuous improvement.
• Production & Scheduling:
• Coordinate the production schedule, ensuring alignment with manufacturing needs and raw material availability, in collaboration with the Supply Chain team.
• Ensure timely execution of tasks in accordance with the production plan and troubleshoot as needed to address operational challenges.
• Monitor production activities to ensure on-time delivery, and compliance with safety, quality, and GMP standards.
• Manufacturing Compliance:
• Ensure full compliance with quality systems and safety standards within the manufacturing support team.
• Lead and oversee the inspection readiness of the manufacturing area, ensuring the facility remains in a continuous state of GMP audit preparedness.
• Oversee document reviews (batch records, SOPs, logbooks) and ensure accuracy, completeness, and timely release of batches.
• Act as a representative for manufacturing during internal or external audits, providing subject matter expertise on manufacturing support functions.
• System & Documentation Management:
• Perform routine transactions in the ERP system, including material requisitions, production tracking, work order updates, and BOM adjustments.
• Create, update, and approve technical documents (SOPs, deviations, protocols) to ensure compliance with GMP and operational standards.
• Maintain up-to-date training records for team members and ensure they are compliant with required certifications and training plans.
• Continuous Improvement & Operational Efficiency:
• Collaborate with other departments to identify and address operational challenges and resource needs.
• Drive continuous improvement initiatives to optimize processes and reduce waste.
• Lead and participate in cross-functional projects to enhance the efficiency of manufacturing support functions.
• Team Development & Training:
• Mentor and develop team members, providing guidance to improve performance and skillsets.
• Ensure that all staff are properly trained on current processes, GMP standards, and safety protocols.
• Support staffing efforts including recruiting, hiring, onboarding, and performance management.
• Administrative & Communication Responsibilities:
• Lead shift exchanges, assign duties, and attend departmental meetings.
• Demonstrate strong communication skills by collaborating with senior management and other departments in a dynamic, fast-paced environment.
• Maintain effective communication through regular emails, reports, and documentation.
• Additional Responsibilities:
• Ensure the cleanliness and readiness of the manufacturing area, including equipment staging, waste disposal, and general housekeeping duties.
• Lead initiatives to improve team performance and meet departmental and organizational objectives.
• Perform other duties as assigned by management.

Qualifications:

• Education/Training:

• Bachelor's degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering).

• Experience:

• Minimum 5 years of experience in a manufacturing or GMP environment, with at least 5 years in a supervisory or leadership role.
• Proven experience with ERP systems (Sage X3 or similar) and document management.
• Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols).

• Knowledge:

• Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements.

• Skills:

• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a fast-paced environment while maintaining high standards of quality and compliance.

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.