GMP Lab Tech Team Lead

Medical University of South Carolina • Charleston, SC

9d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• Serves as the operational technical leader for daily cellular therapy manufacturing and laboratory activities.
• Provides day-to-day technical leadership, workflow coordination, and staff development.
• Ensures safe, efficient, and compliant production of clinical-grade cellular therapy products.
• Functions as the laboratory's primary technical resource and preceptor.
• Promotes standardized practices, technical consistency, and continuous competency development.
• Coordinates daily laboratory operations by assigning and prioritizing technical activities.
• Supports manufacturing readiness and monitors workflow progression.
• Provides real-time technical guidance to laboratory staff.
• Facilitates execution of cellular processing activities including aseptic manufacturing, cell isolation, expansion, enrichment, cryopreservation, analytical testing, and product release support.
• Ensures compliance with cGMP, cGTP, biosafety, contamination control, and institutional quality requirements.
• Serves as the first point of contact for technical troubleshooting.
• Assists with resolution of manufacturing challenges.
• Escalates operational or personnel concerns to laboratory management.
• Develops staff technical competency through structured onboarding, training, direct observation, coaching, and competency assessment.
• Ensures adherence to standardized operating procedures.
• Reinforces best practices in aseptic technique and documentation.
• Supports cross-training initiatives.
• Promotes a culture of continuous learning, quality, and operational excellence.
• Serves as a resource for laboratory personnel by providing technical consultation and sharing subject matter expertise.
• Fosters consistency in manufacturing execution across all shifts and personnel.
• Partners with laboratory leadership to support implementation of new manufacturing processes, equipment, analytical methods, and quality initiatives.
• Contributes technical expertise to investigations, deviations, CAPAs, change controls, equipment qualification, process validation, environmental monitoring, inspection readiness, and continuous improvement activities.
• Helps ensure manufacturing operations remain inspection-ready and compliant with FDA, FACT, CAP, and institutional requirements.
• Assists in evaluating workflow performance and identifying operational improvement opportunities.
• Implements solutions that enhance efficiency, reliability, product quality, and patient safety.
• Serves as the highest operational technical leadership role within the GMP laboratory career pathway.
• Provides technical leadership and mentorship.

Benefits

• Medical University of South Carolina participates in the federal E-Verify program

What This Job Offers

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