Cell Therapy Lab Supervisor - Stem Cell Transplantation Research

The Cell Therapy Lab Supervisor oversees the daily operations and duties related to Good Laboratory Practice (GLP) within the Department of Stem Cell Transplantation Research Lab. This role impacts compliance and quality relating to clinical products.

JOB FUNCTIONS

• Lead and participate in third party and regulatory audits including preparation and responses.
• Supporting process improvement initiatives and maintenance of SOPs
• Author, review, and maintain SOPs, report templates, training plans, annual regulatory refresher training, data trending reports, etc
• Oversee qualification of equipment, systems, and suppliers.
• Organize and supervise employee training.
• Create, revise, and review documents such as SOPs and work instructions.
• Oversee and develop CAPA, deviation, risk analysis and change control management.
• Interacting, reporting, and collaborating with cell engineering and R&D team.
• Ensure appropriate definition, development, and implementation of Quality systems.
• Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.

Other duties as assigned by the Manager.

EDUCATION

Required: Bachelor's degree in a relevant scientific field.

EXPERIENCE

Required: Three years of experience in clinical processing of cellular products and one year of lead or supervisory experience. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience.

OTHER

Required: Must pass pre-employment skills test as required and administered by Human Resources.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html