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Title:  Tissue Engineer I

Division:  Pediatrics
Schedule:  Monday - Friday, 2:00 p.m. - 10:00 p.m. and on cal
Work Location:  Texas Medical Center, Houston, TX
Salary Range:  $55,779 - $72,514
FLSA Status:  Exempt
Requisition ID:  3353
Summary

The Tissue Engineer I performs procedures to include processing, cryopreservation, storage, thawing and disposition of stem cells products and other tissues under rigorous current good manufacturing practices and good tissue practices for use in both the pediatric and adult clinical settings as well as performance of special procedures for use in traditional, new, and experimental therapeutic processes.

Job Duties
  • Perform all approved routine and special procedures on stem cell products for transplantation in both the pediatric and adult patient population.
  • Prepare cell processing and / or administration documentation to ensure all applicable documents are available, correct and in place prior to product processing and/or transplantation.
  • Perform equipment and reagent qualification and maintenance procedures to ensure compliance with manufacturer and regulatory standards for appropriate use.
  • Participate in the generation, validation, revision and implementation of standard operating procedures (SOPs).
  • Communicate with transplant physicians and all other support staff on stem cell product specifications including abnormal findings as appropriate.
  • Ensure daily activities are covered with appropriate staff and communicate staffing issues with co-workers.
  • Perform electronic data entry into CAGT databases, collation of documents for reports and audits, generation of reports and summaries, assistance with materials management, Facility maintenance, upkeep of Facility manuals, and maintenance of Facility master files.
  • Performs approved procedures to generate new cell and tissue products used in somatic and gene therapy treatments.
  • Prepares cell processing documentation in support of FDA reports and submissions.
  • Performs procedure as part of grants and contracts from biotechnology companies and agencies that are developing products for somatic and gene therapy.
  • Participates in validation studies and proficiency testing programs.
  • Ensures materials, reagents and equipment are in compliance with appropriate regulations and standards.
  • Assists in preparation of facility audits, inspections and accreditation visits.
  • Ensures that facility is adequately stocked with materials, reagents and supplies to prepare all currently manufactured somatic cell and gene therapy products.
  • Prepares production batch records and documentation detailing manufacturing activities.
  • Collects and prepares data required as part of FDA-mandated quality management programs.
Minimum Qualifications
  • Education Required: Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
  • Experience Required: Two years of relevant experience.
  • Certification/Licenses/Registration: None Required.
Preferred Qualifications
  • Preferred: Master's degree basic science or related field.
  • Preferred:  Two to five years of relevant experience.
     
Other
  • Able to work flexible hours/ days, as required by the Clinical Program to meet the needs of the patients.
  • Hours are from 2:00 p.m. -10:00 p.m. and as needed on call.

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 3353

CA; CH