MD Anderson Cancer Center Supervisor, Cell Therapy Lab - GMP Laboratory in Houston, Texas
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2018 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Supervisor, Cell Therapy Laboratory position is responsible and accountable for day to day technical and personnel management of the laboratory performing highly specialized, complex and time sensitive cell manipulation and testing procedures on irreplaceable, life saving cellular products used for treatment of cancer patients undergoing Stem Cell Transplantation and/or Cellular Therapy treatment. Supervisor assumes technical responsibility for the release of cell products for infusion to patients.
a.Active supervision of technical staff performing cell manipulation/testing procedures and ensure all approved policies and procedures are implemented and are followed by staff. Ensure proper documentation of deviations, initiate investigation and assist quality assurance in evaluating possible causes, identify corrective actions and assist in timely implementation. Must be able to perform all processing procedures and provide coverage when needed.
b.Coordinate all daily laboratory activities including but not limited to scheduling, workflow, and efficient distribution of clinical products or specific projects, completion of procedures and reports in timely manner. Sudden schedule changes are routine in this laboratory environment due to variable nature of products, patient conditions and possible delays in receipt of products from around the world. Must be able to adapt and adjust workflow in response to these changes in order to meet patient's needs. Must maintain frequent and timely communication with collection and clinic staff regarding schedule changes and ensure flow of information to appropriate laboratory staff.
c.Serve as the technical resource to staff during working and non-working hours. Supervisor must carry a pager at all times and respond to calls in a timely manner. Due to the critical nature of transplant products, facility and certain equipment are being monitored 24 hours a day, 7 days a week. Supervisor serves as the first line of call for the alarms and timely response is required in order to prevent potential loss of patient products.
d.Maintain sufficient and current knowledge of technical procedures, policies and applicability of respective regulations and standards including but not limited to FDA's Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, FACT/Netcord, CAP, CLIA. Ability to educate staff on the technical principles as well as applicable regulatory requirements defined in policies and procedure.
e.Maintain and demonstrate extensive knowledge of technical procedures and ability to troubleshoot independently and train staff. Ability to identify issues and problems, think through possible solutions and implement corrective actions. Identify quality and process improvement projects and lead the development and implementation of such projects.
f.Assist in developing and implementing training program, ensure staff performing procedures are trained and competent in performing the task, maintain up to date training and competency records, identify improvement areas for training of individual staff or program as a whole.
g.Complete performance reviews, manage personnel issues, interview new applicants and assist in the hiring and disciplinary action process.
2.Quality Control and Data Management
a.Review records and approve data for accuracy and completion. Supervisor must ensure designated laboratory staff is trained and competent in performing this function in his/her absence since errors in this area could have a direct patient affect.
b.Responsible for writing and revising technical standard operating procedures and policies. Review SOPs written by other staff and ensure their completeness and accuracy.
c.Demonstrate extensive working and theoretical knowledge of current stem cell transplantation and cellular therapies including but not limited to procurement, processing, testing, storage and transplantation. Knowledge of various cell sources such as bone marrow, peripheral blood stem cells and cord blood is essential for understanding the rationale behind methods. Must ensure staff are trained and are able to apply knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
d.Oversee all required activities related to quality control, proficiency testing, supply availability, equipment quality control and maintenance are completed in timely manner in order to maintain regulatory compliance as well as provide patients with high quality and safe products.
e.Responsible for completion of procedure and equipment validation studies following defined plan and in a timely manner. Assist, guide and manage employees assigned to performing such studies. Compile and provide data to laboratory directors or other designated staff.
3.Technology Transfer and Training
a.Assist in transfer of novel technologies, guide and mentor staff in performance and timely completion of assigned projects.
b.Implement procedures/policies defined by internal or external study sponsors on various clinical trials that may differ from standard operating procedures of MDACC Cell Therapy Laboratory. Maintain knowledge of clinical trial requirement, educate staff and ensure compliance.
c.Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.
4.Perform other duties as required.
Required: Bachelor's degree in a relevant scientific field.
Required: Three years of experience in clinical processing of cellular products and previous lead/supervisor experience.
Preferred: Five years in clinical processing of cellular products and three years of supervisory experience.
Preferred: Certified Medical Technologist (MT) or Medical Laboratory Scientist by the American Society of Clinical Pathologist (ASCP)
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
Employee Status: Regular
Minimum Salary: US Dollar (USD) 68,800
Midpoint Salary: US Dollar (USD) 86,000
Maximum Salary : US Dollar (USD) 103,200