GMP Lab Tech Team Lead

Job Description Summary

The GMP Lab Team Lead serves as the operational technical leader for daily cellular therapy manufacturing and laboratory activities within a highly regulated GMP environment. While remaining actively engaged in complex laboratory and manufacturing operations, this role provides day-to-day technical leadership, workflow coordination, and staff development to ensure the safe, efficient, and compliant production of clinical-grade cellular therapy products. The Team Lead functions as the laboratory's primary technical resource and preceptor, promoting standardized practices, technical consistency, and continuous competency development across GMP laboratory personnel.

The GMP Lab Team Lead coordinates daily laboratory operations by assigning and prioritizing technical activities, supporting manufacturing readiness, monitoring workflow progression, and providing real-time technical guidance to laboratory staff. Working closely with laboratory leadership, quality, clinical, research, and manufacturing partners, the Team Lead facilitates execution of cellular processing activities including aseptic manufacturing, cell isolation, expansion, enrichment, cryopreservation, analytical testing, and product release support while ensuring compliance with cGMP, cGTP, biosafety, contamination control, and institutional quality requirements. The Team Lead serves as the first point of contact for technical troubleshooting, assists with resolution of manufacturing challenges, and escalates operational or personnel concerns to laboratory management as appropriate.

As the laboratory's primary preceptor and technical mentor, the GMP Lab Team Lead develops staff technical competency through structured onboarding, training, direct observation, coaching, and competency assessment. The role ensures adherence to standardized operating procedures, reinforces best practices in aseptic technique and documentation, supports cross-training initiatives, and promotes a culture of continuous learning, quality, and operational excellence. The Team Lead serves as a resource for laboratory personnel by providing technical consultation, sharing subject matter expertise, and fostering consistency in manufacturing execution across all shifts and personnel.

The GMP Lab Team Lead partners with laboratory leadership to support implementation of new manufacturing processes, equipment, analytical methods, and quality initiatives. The role contributes technical expertise to investigations, deviations, CAPAs, change controls, equipment qualification, process validation, environmental monitoring, inspection readiness, and continuous improvement activities while helping ensure manufacturing operations remain inspection-ready and compliant with FDA, FACT, CAP, and institutional requirements. The Team Lead assists in evaluating workflow performance, identifying operational improvement opportunities, and implementing solutions that enhance efficiency, reliability, product quality, and patient safety.

The GMP Lab Team Lead serves as the highest operational technical leadership role within the GMP laboratory career pathway, bridging advanced laboratory expertise, technical training, manufacturing coordination, and quality excellence while supporting laboratory leadership in the successful execution of cellular therapy manufacturing programs. This position provides technical leadership and mentorship but does not have formal supervisory responsibilities for employee performance management, disciplinary actions, hiring, compensation, or other human resources functions.

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type​

Regular

Cost Center

CC005736 CHS - CCCT Lab

Pay Rate Type

Salary

Pay Grade

Health-28

Scheduled Weekly Hours

40

Work Shift

Job Description

Education and Work Experience:

• Master’s college degree with major in medical technology or biological sciences
• 5+ years clinical cell therapy experience
• 2+ years of leadership experience
• Experience working within an academic cGMP laboratory, including familiarity with FDA and FACT accreditation requirements
• Flow cytometry expertise
• Advanced hematology knowledge
• Motivation and initiative to learn new scientific theory and applications
• Mature judgment
• Work independently with regular review of progress and results
• Collaborate and communicate effectively across direct and indirect laboratory and clinical functions
• Highly experienced with documentation and data interpretation
• Serves as technical expert across multiple cell types
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports
• Advanced math skills
• Advanced communication skills
• Must be able to differentiate between colors and pass a standardized color vision screen to perform this role

 

Preferred Qualifications:

• Doctorate college degree with major in medical sciences or related field
• Cell selection operation experience (e.g., manual or CliniMACs)
• Moderate immunotherapy or regenerative medicine experience
• Strong experience with various LIS programs (e.g., Bluecord, Stemsoft)
• A masterful understanding of cGMP/cGTP 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 include: 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

Education and Work Experience:

· Master’s college degree with major in medical technology or biological sciences

· 5+ years clinical cell therapy experience

· 2+ years of leadership experience

· Experience working within an academic cGMP laboratory, including familiarity with FDA and FACT accreditation requirements

· Flow cytometry expertise

· Advanced hematology knowledge

· Motivation and initiative to learn new scientific theory and applications

· Mature judgment

· Work independently with regular review of progress and results

· Collaborate and communicate effectively across direct and indirect laboratory and clinical functions

· Highly experienced with documentation and data interpretation

· Serves as technical expert across multiple cell types

· Scientific writing skills, including preparation of clear, concise SOPs and technical reports

· Advanced math skills

· Advanced communication skills

· Must be able to differentiate between colors and pass a standardized color vision screen to perform this role

Preferred Qualifications:

· Doctorate college degree with major in medical sciences or related field

· Cell selection operation experience (e.g., manual or CliniMACs)

· Moderate immunotherapy or regenerative medicine experience

· 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.

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