Cell Processing & GMP Laboratories Manager, Cellular Therapy

MUSC Health; Charleston (SC); On-site; USD 110,000 - 160,000; Full time

Job summary

Medical University of South Carolina seeks a Lab Manager to provide strategic and operational leadership for the Cell Processing and GMP laboratories, ensuring CGMP compliance and high-quality services for cell therapy patients and research. The role collaborates with clinical, quality, research and admin leaders to advance cellular therapy programs.

Responsibilities include regulatory readiness, quality systems, personnel management, and continuous improvement across lab environments, with a

Qualifications

• Master’s degree in medical technology or biological sciences required.
• 5+ years cell therapy lab experience, GMP or processing lab.
• 5+ years leadership experience.
• Familiarity with FDA and FACT accreditation requirements.

Responsibilities

• Provide strategic and operational leadership for two laboratories (Cell Processing and GMP Lab).
• Ensure safe, compliant operation and high-quality services for patient care, research, and biomanufacturing.
• Lead regulatory readiness, quality systems, and continuous improvement initiatives.
• Collaborate with clinical, physician, quality, research, and admin leaders to achieve operational excellence.

Skills

Leadership

Communication

Documentation

Data interpretation

Color vision

Immunotherapy experience

Education

Master’s degree in medical technology or biological sciences

5+ years cell therapy lab experience

5+ years leadership experience

Experience with FDA and FACT accreditation

Doctorate degree preferred

Tools

Bluecord

Stemsoft

Job description

Job Description Summary

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.

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.

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type

Regular

Cost Center

CC005736 CHS - CCT Lab

Pay Rate Type

Salary

Pay Grade

Health-33

Scheduled Weekly Hours

40

Education and Work Experience

• 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

Preferred Qualifications

• 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 cGTP/cGMP standards
• undefinedPhysical Requirements: Physical Requirements: 1) (C) Continuous – 6-8 hours per shift; 2) (F) Frequent – 2-6 hours per shift; 3) (I) Infrequent – 0-2 hours per shift 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) Examples including: To transfer a 100 lb. patient that cannot assist in the transfer requires 50 lbs. of force. For every 100 additional pounds, assistance will be required from another healthcare worker. 20 lbs. of force is needed to push a 400 lb. patient in a wheelchair on carpet. 25 lbs. of force is required to push a stretcher with a patient with one hand. 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) *(Selected Positions) *Ability to maintain good olfactory sensory function. (C) *(Selected Positions) *Ability to be qualified physically for respirator use, initially and as required. (C) (Selected Positions) *Must pass respirator fit test.

Additional Job Description

• 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

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees