Summary

The Tissue Engineer I 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, investigational cell and gene therapy products still in clinical development. The Tissue Engineer I works closely with clinical and regulatory staff to ensure products meet release criteria before use, and contributes to the ongoing development and revision of standard operating procedures as the program's therapies evolve.  In addition to routine transplant-support processing, this position may assist with sample preparation and testing for adventitious agent screening (e.g., sterility, HPV, mycoplasma) on master cell banks and investigational products, support the execution of process validation studies for new assays, and assist in preparing documentation used in regulatory submissions and responses to FDA information requests. Ideal candidate will be able to work a flexible work schedule including days, evenings, overnights and weekends.

Job Duties

• Perform cryopreservation, thawing, and release testing of hematopoietic stem cell and commercial T-cell products, including coordination of sterility and identity testing (e.g., BACTEC culture, flow cytometry, ect) prior to product release for infusion.
• Prepare and review batch records, donor eligibility documentation, chain-of-custody documentation, and release checklists for both licensed transplant products and IND-stage investigational cell and gene therapy products, ensuring documentation meets both institutional and FDA expectations. 
• Perform qualification, calibration verification, and routine maintenance of GMP processing equipment (e.g., controlled-rate freezers, biosafety cabinets, CliniMACS plus) per manufacturer specifications and departmental SOPs.
• Participate in drafting and revising SOPs and validation worksheets for new assays and processes (e.g., stability studies), 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, sponsor monitoring visits, and internal QA reviews. 
• Perform other job related duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree
• Strong attention to detail and comfort working within regulated documentation and audit environments
• Prior experience in a cGMP or clinical laboratory setting, particularly cell processing, cryopreservation, or cell/gene therapy manufacturing
• Familiarity with microbiological release testing methods (e.g., culture-based sterility testing)
• Experience with electronic health record or laboratory information systems (e.g., Epic)