Cell Processing & GMP Laboratories Manager, Cellular Therapy

Medical University of South Carolina • Charleston, SC

3d • Onsite

About The Position

The Lab Manager provides operational, technical, and administrative leadership for the Cell Processing Laboratory and GMP Laboratory supporting cell and gene therapy patient needs. The Cell Processing Laboratory supports the processing, testing, storage, and distribution of cellular therapy products for clinical transplantation, while the GMP Laboratory manufactures clinical-grade cell and gene therapy products in compliance with current Good Manufacturing Practices (cGMP). The Lab Manager is accountable for the safe, efficient, and compliant operation of both laboratories, ensuring high-quality laboratory services that support patient care, research, and biomanufacturing. This role provides strategic and operational oversight for laboratory operations, quality systems, regulatory compliance, personnel management, and continuous improvement across both laboratory environments. The Lab Manager leads daily operations, develops and mentors staff, manages laboratory resources, and partners with clinical, physician, quality, research, and administrative leaders to ensure operational excellence, regulatory readiness, and successful execution of cellular therapy programs. The position is responsible for fostering a culture of safety, accountability, collaboration, and innovation while advancing the strategic goals and continued growth of the cellular therapy ICCE. The role contributes technical expertise to investigations, deviations, CAPAs, change controls, inspection readiness, and continuous improvement activities while helping ensure manufacturing operations maintain compliance with FDA, FACT, AABB, and other institutional requirements.

Requirements

• Master’s college degree with major in medical technology or biological sciences
• 5+ years cell therapy lab experience (either GMP lab or cell processing lab will suffice)
• 5+ years of leadership experience
• Experience working within an academic Cell Processing laboratory and cGMP laboratory, including familiarity with FDA and FACT accreditation requirements
• Motivation and initiative to learn new scientific theory and applications
• Mature judgment
• Highly experienced with documentation and data interpretation
• Serves as technical expert across multiple cell types
• Advanced leadership skills
• Advanced communication skills
• Must be able to differentiate between colors and pass a standardized color vision screen to perform this role
• Moderate immunotherapy or regenerative medicine experience

Nice To Haves

• Doctorate college degree with major in medical sciences or related field
• Moderate experience with minimal and more than minimal manipulation of cellular products
• Strong experience with various LIS programs (e.g., Bluecord, Stemsoft)
• A masterful understanding of cGMP/cGTP standards

Responsibilities

• Provides operational, technical, and administrative leadership for the Cell Processing Laboratory and GMP Laboratory.
• Accountable for the safe, efficient, and compliant operation of both laboratories.
• Ensures high-quality laboratory services that support patient care, research, and biomanufacturing.
• Provides strategic and operational oversight for laboratory operations, quality systems, regulatory compliance, personnel management, and continuous improvement.
• Leads daily operations, develops and mentors staff, and manages laboratory resources.
• Partners with clinical, physician, quality, research, and administrative leaders.
• Fosters a culture of safety, accountability, collaboration, and innovation.
• Advances the strategic goals and continued growth of the cellular therapy ICCE.
• Contributes technical expertise to investigations, deviations, CAPAs, change controls, inspection readiness, and continuous improvement activities.
• Helps ensure manufacturing operations maintain compliance with FDA, FACT, AABB, and other institutional requirements.

Benefits

• Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager