Tissue Engineer I

The Center for Cell and Gene Therapy at Baylor College of Medicine is seeking a Tissue Engineer I to support vital GMP manufacturing operations. This role focuses on the processing, cryopreservation, storage, and release of cellular products utilized in adult and pediatric clinical programs. The successful candidate will perform hands-on laboratory procedures adhering to current Good Manufacturing Practice standards while maintaining meticulous regulatory documentation. Working closely with clinical and quality teams, the appointee will contribute to standard operating procedure revisions, equipment maintenance, and product safety testing.

• Execute cryopreservation, thawing, and release testing procedures for hematopoietic stem cell and commercial T-cell products.
• Prepare, review, and maintain rigorous batch records, chain-of-custody documentation, and donor eligibility files in compliance with FDA and institutional standards.
• Perform routine calibration, qualification, and maintenance of specialized GMP processing equipment such as controlled-rate freezers and biosafety cabinets.
• Collaborate with quality assurance teams to draft and revise standard operating procedures and validation worksheets for novel assays.
• Coordinate sterility, identity, and adventitious agent testing including flow cytometry and culture-based assays prior to clinical product release.
• Communicate product availability, out-of-specification results, and schedule deviations directly with transplant physicians and study teams.
• Manage processing and release records using electronic laboratory information systems and compile documentation for audits.