Able to work flexible hours/days, as required by the Clinical Program to meet the needs of the patients.
Perform 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.
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).
Participate in appropriate proficiency testing programs.
Ensure materials, reagents and equipment are in calibration and in date prior to use.
Assist in preparation of facility audits, inspections and accreditation visits.
Ensure that facility is adequately stocked with materials, reagents and supplies to prepare all currently manufactured stem cell products and gene therapy products(when applicable).
Prepare production batch records and documentation detailing manufacturing activities.
Ensure daily activities are covered with appropriate staff and is able to 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, maintenance of Facility master files.
Bachelor's degree in a basic science or equivalent experience in relevant biotechnology area and experience of GMP/GTP.
Two years research experience.
Must have experience with aseptic technique, tissue preparation and cell handling.
Great attention to detail and meticulous ability to organize documentation.
Knowledge of basic computer software including word processing, spreadsheets and databases.
Able to openly communicate with transplant physicians and all other support staff on stem cell product specifications including abnormal findings as appropriate.
Baylor College Of Medicine