What are the responsibilities and job description for the Good Lab Practices (GLP) Laboratory Manager – Bioprocessing & 3D Biomanufacturing position at Terasaki Institute for Biomedical Innovation?
About the Role
The Terasaki Institute for Biomedical Innovation is seeking a highly motivated and experienced GLP Laboratory Manager to lead and manage our newly expanded GLP-compliant biomanufacturing space. This individual will oversee operations related to induced pluripotent stem cell (iPSC) bioprocessing, bioreactor systems, and GLP-aligned 3D bioprinting platforms for regenerative medicine and translational research applications.
This is a unique opportunity to build and scale state-of-the-art infrastructure in a rapidly growing environment, working closely with scientists, engineers, and regulatory teams.
Key Responsibilities
- Lead day-to-day operations of the GLP laboratory, ensuring full compliance with FDA GLP guidelines (21 CFR Part 58).
- Oversee implementation and documentation of Standard Operating Procedures (SOPs) and quality systems.
- Manage and maintain bioreactors, cell culture systems, and 3D bioprinting equipment used for GLP iPSC-based studies.
- Coordinate facility readiness, validation, calibration, and routine audits in collaboration with quality assurance personnel.
- Work closely with project leads and PIs to support GLP studies, including data integrity, traceability, and reporting.
- Train and supervise technical staff in GLP-compliant workflows, sample tracking, and biomanufacturing protocols.
- Support documentation and reporting for regulatory submissions and funding agencies (e.g., FDA, ARPA-H, NIH).
- Facilitate technology transfers and scale-up strategies for translational iPSC platforms.
Qualifications
- Bachelor's degree in biomedical engineering, biotechnology, biology, or a related field (Master’s or higher preferred).
- Minimum 3–5 years of hands-on GLP or GMP lab experience, ideally in cell therapy, tissue engineering, or biomanufacturing.
- Strong familiarity with FDA GLP guidelines, QA/QC systems, and regulatory documentation.
- Experience with bioreactors, 3D bioprinters, and iPSC culture or differentiation workflows.
- Proven leadership, organizational, and communication skills in cross-functional settings.
