GMP Lab Tech II-3

musc; Charleston (SC); On-site; USD 71,635,000 - 114,616,000; Full time

Job summary

The GMP Lab Tech II role at MUHA supports advanced cellular therapy manufacturing in a regulated environment. Responsibilities include aseptic processing, cell isolation, expansion, cryopreservation, and quality control across CAR-T and stem cell platforms.

Ideal candidates hold a 4-year degree in medical technology or biological sciences with 2+ years of cell therapy experience and strong data interpretation, documentation, and teamwork skills.

Qualifications

• Four-year college degree with major in medical technology or biological sciences.
• 2+ years clinical cell therapy experience.
• Basic hematology knowledge and data interpretation skills.
• Excellent documentation and scientific writing abilities.
• Color vision and attention to detail required.

Responsibilities

• Perform aseptic processing and complex cellular workflows (isolation, expansion, enrichment, selection, culture, cryopreservation).
• Conduct quality control testing and product characterization in a cGMP setting.
• Maintain batch records, ensure traceability, and support process improvements.

Skills

Cell culture techniques

Flow cytometry

Quality control testing

Data interpretation

Laboratory documentation

Team collaboration

Troubleshooting

Scientific writing

Attention to detail

Color vision screen

Color differentiation

Education

Bachelor's degree in medical technology or biological sciences

Master's degree preferred

2+ years clinical cell therapy experience

Tools

CliniMACs

Bluecord

Stemsoft LIS

Flow cytometer

Job description

Job Description 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 - CCCT Lab

Pay Rate Type: Hourly

Pay Grade: Health-26

Scheduled Weekly Hours: 40

Work Shift

Education and Work Experience :

• 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

Preferred 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

Physical 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 coordinati