GMP Lab Tech II-2
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 development, optimization, validation, and implementation of novel cellular therapy manufacturing processes (e.g., CAR-T, mesenchymal stem cell, dendritic cell).
- Contributes to process improvement initiatives, equipment and procedure qualification, and SOP development.
- Performs complex immunological, hematological, and cellular analyses for product characterization and assay validation.
- Utilizes advanced laboratory techniques including flow cytometry, ELISA-based assays, functional immune testing, and cellular analysis.
- Evaluates product performance, investigates technical challenges, and generates data to support manufacturing decisions.
- Serves as a critical technical contributor, bridging laboratory expertise, manufacturing execution, and quality oversight.
Benefits
- Participates in the federal E-Verify program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
