Tissue Engineer I - Pediatrics - Hematology & Oncology - Cell Therapy

Baylor College of Medicine

Houston, TX

Job posting number: #7080339 (Ref:7487-en_US)

Posted: June 23, 2021

Application Deadline: Open Until Filled

Job Description

Summary

The Tissue Engineer I performs procedures to include processing, cryopreservation, storage, thawing and disposition of stem cell 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. Primary shift 2:00 p.m. - 10:00 p.m. with flexiblity to work day shift as needed, also rotation for weekly on call.

Job Duties

  • Performs all approved routine and special procedures on stem cell products for transplantation in both the pediatric and adult patient population.
  • Prepares cell processing and / or administration documentation to ensure all applicable documents are available, correct and in place prior to product processing and/or transplantation.
  • Performs equipment and reagent qualification and maintenance procedures to ensure compliance with manufacturer and regulatory standards for appropriate use.
  • Participates in the generation, validation, revision and implementation of standard operating procedures (SOPs).
  • Communicates with transplant physicians and all other support staff on stem cell product specifications including abnormal findings as appropriate.
  • Ensures daily activities are covered with appropriate staff and communicate staffing issues with co-workers.
  • Performs 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

  • 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.

 

 

 

 

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

 7487

CA 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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