GMP Lab Tech II-3

Summary The GMP Lab Tech II performs advanced cellular therapy manufacturing and laboratory operations supporting clinical, translational, and investigational cell therapy programs within a highly regulated GMP environment. This role is responsible for the execution of complex cellular processing workflows, including cell isolation, expansion, enrichment, selection, culture, cryopreservation, and quality control testing of human-derived cellular products used in clinical care and therapeutic development.

The GMP Lab Tech II supports end-to-end manufacturing operations for advanced cellular therapies by performing aseptic processing activities within classified cleanroom environments, maintaining accurate batch documentation, and ensuring product traceability, compliance, and quality throughout the manufacturing lifecycle. The role applies specialized technical expertise in the processing of apheresis-derived products, immune cell populations, stem cell products, and emerging cellular therapies, while adhering to established cGMP, cGTP, biosafety, and contamination control requirements.

In collaboration with clinical, laboratory, research, and quality teams, the GMP Lab Tech II supports the development, optimization, validation, and implementation of novel cellular therapy manufacturing processes, including CAR-T, mesenchymal stem cell, dendritic cell, and other advanced therapeutic platforms. The role contributes to process improvement initiatives, equipment and procedure qualification activities, SOP development, and implementation of standardized workflows that enable the translation of innovative cellular therapies from research environments into clinical application.

The GMP Lab Tech II performs complex immunological, hematological, and cellular analyses to support product characterization, assay validation, and laboratory quality programs. Through advanced laboratory techniques including flow cytometry, ELISA-based assays, functional immune testing, and cellular analysis, this role evaluates product performance, investigates technical challenges, and generates data to support manufacturing decisions and continuous improvement.

The GMP Lab Tech II serves as a critical technical contributor within the cellular therapy program, bridging laboratory expertise, manufacturing execution, and quality oversight to support the safe, reliable, and compliant delivery of next-generation cellular therapies. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type​ Regular Cost Center CC005736 CHS - CCT Lab Pay Rate Type Hourly Pay Grade Health-26 Scheduled Weekly Hours 40 Work Shift

Education and Work

Four-year college degree with major in medical technology or biological sciences 2+ years clinical cell therapy experience Basic hematology knowledge Motivation and initiative to learn new scientific theory and applications Mature judgment Work independently with regular review of progress and results Proven team player Collaborate and communicate effectively across functions Interpret data thoroughly Strong trouble-shooting capabilities Scientific writing skills, including preparation of clear, concise SOPs and technical reports Strong math skills Attention to detail Must be able to differentiate between colors and pass a standardized color vision screen to perform this role

Master’s college degree with a major in medical sciences or related field Experience working within an academic cGMP laboratory, including familiarity with FDA and FACT accreditation requirements Flow cytometry expertise Immunotherapy experience Cell selection operation experience (e.g., manual or CliniMACs) Moderate LIS knowledge (e.g., Bluecord, Stemsoft) A strong understanding of cGMP/cGTP standards Physical

Physical

• 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

Education and Work

• Four-year college degree with major in medical technology or biological sciences
• 2+ years clinical cell therapy experience
• Basic hematology knowledge
• Motivation and initiative to learn new scientific theory and applications
• Mature judgment
• Work independently with regular review of progress and results
• Proven team player
• Collaborate and communicate effectively across functions
• Interpret data thoroughly
• Strong trouble-shooting capabilities
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports
• Strong math skills
• Attention to detail
• Must be able to differentiate between colors and pass a standardized color vision screen to perform this role

• Master’s college degree with a major in medical sciences or related field
• Experience working within an academic cGMP laboratory, including familiarity with FDA and FACT accreditation requirements
• Flow cytometry expertise
• Immunotherapy experience
• Cell selection operation experience (e.g., manual or CliniMACs)
• Moderate LIS knowledge (e.g., Bluecord, Stemsoft)
• A strong 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