Perform 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.
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.
Bachelor's degree in a basic science or equivalent experience in relevant biotechnology area and experience of GMP/GTP.
Two years research experience.
Ability to work flexible hours/days, as required by the Clinical Program to meet the needs of the patients; Work hours are from 2:00 p.m. - 10:00 p.m.
Aseptic technique, tissue preparation, and cell handling.
Excellent organizational skills with a great attention to detail.
Computer proficient in basic computer software including word processing, spreadsheets and databases.
Frequently handles/works with biohazards or risks for potential job related injury, such as those found in an ordinary laboratory or clinic environment.
Baylor College Of Medicine