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

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Company: Terasaki Institute for Biomedical Innovation

Location: Woodland Hills, CA 91367

Description:

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.

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