Cell Processing & GMP Laboratories Manager, Cellular Therapy

Medical University of South Carolina•Charleston, SC

4d•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
Ability to perform job functions while standing. (C)
Ability to perform job functions while sitting. (C)
Ability to perform job functions while walking. (Continuous)
Ability to climb stairs. (I)
Ability to work indoors. (C)
Ability to work outside in temperature extremes. (I)
Ability to work from elevated areas. (F)
Ability to work in confined/cramped spaces. (F)
Ability to perform job functions from kneeling positions. (I)
Ability to bend at the waist. (C)
Ability to twist at the waist. (F)
Ability to squat and perform job functions. (F)
Ability to perform “pinching” operations. (F)
Ability to perform gross motor activities with fingers and hands. (C)
Ability to perform firm grasping with fingers and hands. (C)
Ability to perform fine manipulation with fingers and hands. (C)
Ability to reach overhead. (F)
Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (C)
Ability to fully use both legs. (C)
Ability to use lower extremities for balance and coordination. (F)
Ability to reach in all directions. (C)
Ability to lift and carry 50 lbs. unassisted. (I)
Ability to lift/lower objects 50 lbs. from/to floor from/to 36 inches unassisted. (I)
Ability to lift from 36” to overhead 25 lbs. (I)
Ability to exert up to 50 lbs. of force. (F)
Ability to maintain vision 20/40 corrected. (C)
Ability to see and recognize objects close at hand or at a distance. (C)
Ability to match or discriminate between colors. (C)
Ability to determine distance/relationship between objects; depth perception. (C)
Good peripheral vision capabilities. (C)
Ability to maintain hearing acuity, with correction. (C)
Ability to perform gross motor functions with frequent fine motor movements. (C)
Ability to deal effectively with stressful situations. (C)
Ability to work rotating shifts. (F)
Ability to work overtime as required. (F)
Ability to work in a latex safe environment. (C)
Ability to maintain tactile sensory functions. (C)
Ability to maintain olfactory sensory function. (C)
Ability to be qualified physically for respirator use, initially and as required. (C)
Must pass respirator fit test.

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.
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.