Good Lab Practices (GLP) Laboratory Manager Bioprocessing & 3D

Job Description

Salary: 90,000-100,000

Salary: DOE, $90,000-$100,000 and a comprehensive benefits package

Job Summary

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.

This is a year appointment, with the potential for extension based on research progress.

Job Accountabilities:

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.

Please visit terasaki.org for more information

ADDITIONAL INFORMATION

Required Education: Bachelor's degree in biomedical engineering, biotechnology, biology, or a related field (Masters or higher preferred).

Required Experience: Minimum 35 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.

The duties and responsibilities described are not a comprehensive list and that additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands.

TIBI is committed to equal employment opportunities. We value emotional intelligence and communication with empathy and respect for others. We seek to build a diverse group of people who are curious, have a deep sense of responsibility, and the grit needed to achieve excellence.

Full-time