Tissue Engineer I - GMP Cell Therapy (Flexible Schedule)

Baylor College of Medicine (BCM); Houston (TX); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

The Tissue Engineer I at Baylor College of Medicine supports the Center for Cell and Gene Therapy's GMP manufacturing operations, handling the processing, cryopreservation, storage, and release of stem cell and other cellular products used in pediatric and adult transplant and cell/gene therapy programs.

This role carries out hands-on laboratory procedures under current Good Manufacturing Practice (cGMP) standards, supporting both established stem cell transplant protocols and novel,

Qualifications

• Bachelor's degree in a Basic Science or related field (4 years of related experience may substitute).
• Two years of relevant experience required.
• Experience in regulated laboratory environments is preferred.

Responsabilités

• Perform cryopreservation, thawing, and release testing of stem cell and T-cell products.
• Prepare and review batch records, donor eligibility, and release checklists for licensed and IND products.
• Maintain GMP processing equipment with routine calibration and maintenance.
• Draft and revise SOPs and validation worksheets for new assays and processes.
• Communicate with transplant physicians and study teams regarding release status and deviations.
• Maintain records in Epic and CAGT LIMS; assemble documents for audits and regulatory requests.
• Perform other job related duties as assigned.

Connaissances

Two years of experience

Formation

Bachelor's degree in a Basic Science or related field

Description du poste

The Tissue Engineer I at Baylor College of Medicine supports the Center for Cell and Gene Therapy's GMP manufacturing operations, handling the processing, cryopreservation, storage, and release of stem cell and other cellular products used in pediatric and adult transplant and cell/gene therapy programs.

This role carries out hands-on laboratory procedures under current Good Manufacturing Practice (cGMP) standards, supporting both established stem cell transplant protocols and novel,