Plans, coordinates and optimizes processing of clinical hematopoietic stem cell products used for stem cell transplants. Acts as an administrator of Stem Cell Processing Laboratory (SCPL) and provides guidance to Medical Directors and physicians.Job Purpose
Plans, coordinates, and optimizes general and scientific needs of a Baylor College of Medicine laboratory. Provides professional guidance and technical support to faculty and principal investigators and acts as an administrator of an assigned College laboratory.Job Duties
- Maintain laboratory compliance with FDA and Foundation for the Accreditation of Cellular Therapy (FACT) standards.
- Plan and organize administrative operations of the laboratory, such as manages schedule that includes training in, and performance of, clinical cell processing procedures.
- Manage patient schedules.
- Follow-up on patient progress. Must be available 24/7/365 to perform these duties.
- Review of processing charts and patient outcomes.
- Submit incidents and deviations reports and assists Quality Assurance to investigate root causes and develop immediate and long term corrective actions.
- Plan and write reports of process validations.
- Assist QA with Biological Products Deviation Reports with FDA.
- Provide QA with quality indicators for quarterly reports.
- Prepare for audits by the FDA. Foundation for the Accreditation of Cellular Therapy, and professional organizations.
- Bachelor's degree in a Basic Science or a related field.
- Five years of relevant experience.
- Master's degree in a related field.
- Experience in stem cell processing will be a great asset.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
CA; CH; SN