GMP Lab Tech II-3

Medical University of South Carolina; Orleans Estates (SC); On-site; USD 55,000 - 75,000; Full time

Job summary

The GMP Lab Tech II at Medical University of South Carolina performs advanced cellular therapy manufacturing and laboratory operations within a regulated GMP environment, handling cellular processing workflows from isolation to cryopreservation.

This role collaborates with clinical, research, and quality teams to optimize processes, validate manufacturing methods, and ensure product traceability, compliance, and high-quality data supporting therapeutic development.

Qualifications

• Four-year college degree with major in medical technology or biological sciences
• 2+ years clinical cell therapy experience
• Basic hematology knowledge
• Strong trouble-shooting capabilities
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports

Responsibilities

• Perform advanced cellular therapy manufacturing and laboratory operations in a GMP environment
• Execute aseptic processing in classified cleanrooms with accurate batch documentation
• Support end-to-end manufacturing for cellular therapies including CAR-T, stem cell products, and related platforms
• Perform product characterization and quality testing using flow cytometry and ELISA-based assays
• Collaborate with cross-functional teams to develop and implement new manufacturing processes

Skills

Flow cytometry

Data interpretation

Scientific writing

Education

Bachelor's degree in medical technology or biological sciences

2+ years clinical cell therapy experience

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.

Qualifications

• 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

Require continuous, frequent, or infrequent ability to stand, sit, walk, climb stairs, work indoors and outdoors in temperature extremes, work in confined spaces, perform gross motor and fine motor tasks, lift and carry. Specific functional requirements include:

• Ability to lift and carry 50 lbs. unassisted.
• Ability to lift 50 lbs. from floor or 36 inches, and lift from 36” to overhead 25 lbs.
• Ability to exert up to 50 lbs. of force.
• Maintain vision 20/40 corrected, discriminate colors, depth perception, peripheral vision, hearing acuity.
• Maintain respiratory fit test (must pass respirator fit test).

Other functional requirements as applicable.

Equal Employment Opportunity

The Medical University of South Carolina is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Employee Verification

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 visit http://www.uscis.gov/e-verify/employees.