GMP Lab Tech II-1

About the role

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.

Responsibilities

• Execute 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.
• Support 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.
• Apply 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.
• Collaborate with clinical, laboratory, research, and quality teams to support 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.
• Contribute 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.
• Perform complex immunological, hematological, and cellular analyses to support product characterization, assay validation, and laboratory quality programs.
• Evaluate product performance, investigate technical challenges, and generate data to support manufacturing decisions and continuous improvement.
• Serve 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.

Requirements

• Four-year college degree with major in medical technology or biological sciences
• Two to three 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

Qualifications

• 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

Skills

• Advanced laboratory techniques including flow cytometry, ELISA-based assays, functional immune testing, and cellular analysis
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports
• Strong math skills
• Attention to detail
• Ability to differentiate between colors and pass a standardized color vision screen

Benefits

Not specified

Pay

Hourly pay grade Health-26

Schedule

Rotating shifts

Additional Information

Physical Requirements: Continuous – 6-8 hours per shift; Frequent – 2-6 hours per shift; Infrequent – 0-2 hours per shift

Ability to perform job functions while standing, sitting, walking, climbing stairs, twisting, squatting, reaching overhead, performing repetitive motions, lifting and carrying 50 lbs. unassisted, pushing/pulling objects 50 lbs. from/to floor from/to 36 inches unassisted, lifting from 36” to overhead 25 lbs. unassisted, exerting up to 50 lbs. of force, maintaining vision 20/40 corrected, matching or discriminating between colors, determining distance/relationship between objects; depth perception, good peripheral vision capabilities, maintaining hearing acuity, with correction, performing gross motor functions with frequent fine motor movements, dealing effectively with stressful situations, working rotating shifts, working overtime as required, working in a latex safe environment, passing respirator fit test, being qualified physically for respirator use, initially and as required.

Medical University of South Carolina is an Equal Opportunity Employer.