GMP Lab Tech II-2

Medical University of South Carolina•Charleston, SC

7d•Onsite

About The Position

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.

Requirements

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
Ability to work independently with regular review of progress and results
Proven team player
Ability to collaborate and communicate effectively across functions
Ability to 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

Nice To Haves

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

Responsibilities

Performs advanced cellular therapy manufacturing and laboratory operations.
Executes complex cellular processing workflows: cell isolation, expansion, enrichment, selection, culture, cryopreservation, and quality control testing.
Performs aseptic processing activities within classified cleanroom environments.
Maintains accurate batch documentation and ensures product traceability, compliance, and quality.
Applies specialized technical expertise in processing apheresis-derived products, immune cell populations, stem cell products, and emerging cellular therapies.
Adheres to established cGMP, cGTP, biosafety, and contamination control requirements.
Supports the development, optimization, validation, and implementation of novel cellular therapy manufacturing processes.
Contributes to process improvement initiatives, equipment and procedure qualification activities, SOP development, and implementation of standardized workflows.
Performs complex immunological, hematological, and cellular analyses to support product characterization, assay validation, and laboratory quality programs.
Evaluates product performance, investigates technical challenges, and generates data to support manufacturing decisions and continuous improvement using advanced laboratory techniques.
Serves as a critical technical contributor within the cellular therapy program.