GMP Tissue Engineer I: Cell Therapy & Cryopreservation

Baylor College of Medicine; Houston (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Baylor College of Medicine's Center for Cell and Gene Therapy is seeking a Tissue Engineer I to support GMP manufacturing of stem cell and cellular products for transplant and gene therapy programs. You will work hands-on to ensure product release criteria are met, maintain batch records in Epic, and assist with SOPs and FDA/IRB documentation.

Flexible schedule possible for days, evenings, overnights, and weekends.

Qualifications

• Bachelor's degree in a Basic Science or related field required.
• Two years of relevant experience.

Responsibilities

• Perform cryopreservation, thawing, and release testing of hematopoietic stem cell and commercial T-cell products, including coordination of sterility and identity testing prior to product release for infusion.
• Prepare and review batch records, donor eligibility documentation, chain-of-custody documentation, and release checklists for licensed transplant products and IND-stage investigational cell and gene therapy products, ensuring documentation meets institutional and FDA expectations.
• Perform qualification, calibration verification, and routine maintenance of GMP processing equipment per manufacturer specifications and SOPs.
• Participate in drafting and revising SOPs and validation worksheets for new assays and processes, including supporting method validation studies under QA oversight.
• Communicate directly with transplant physicians and study teams regarding product release status, out-of-specification results, and any deviations affecting product availability or timing.
• Maintain processing and release records in Epic and CAGT's laboratory information systems, and assemble documentation for FDA/IRB audits and sponsor monitoring visits.
• Perform other job related duties as assigned.

Education

Bachelor's degree in a Basic Science or related field

Job description

Baylor College of Medicine's Center for Cell and Gene Therapy is seeking a Tissue Engineer I to support GMP manufacturing of stem cell and cellular products for transplant and gene therapy programs. You will work hands-on to ensure product release criteria are met, maintain batch records in Epic, and assist with SOPs and FDA/IRB documentation.

Flexible schedule possible for days, evenings, overnights, and weekends.