Assistant Director, Cell & Gene Therapy Laboratory

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 Assistant (Asst) Director, Cell & Gene Therapy Laboratory (CTL) Good Manufacturing Practice (GMP) facility is responsible for the overall clinical, administrative, and resource management of the CTL GMP facility to direct, coordinate, develop and continually improve all operational aspects of the GMP. In collaboration with the senior management team develops strategic opportunities to improve and optimize the GMP operations. Provide technical leadership and direction to maintain compliance to national and international regulatory standards, and maintain accreditation and license status. Work collaboratively with internal and external departments who request or provide services to the GMP.

KEY FUNCTIONS

1. Laboratory Management and Operations
a. Serve as backup to the Technical Director and Supervisor(s) for areas including but limited to data entry, facility issues and asset management and documentation review.
b. Responsible for laboratory functions including but not limited to cell processing and infusion procedures including calculations, aseptic handling of products, weekly scheduling and data analysis. Must have technical expertise to perform the procedures and advanced troubleshooting. 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 schedule changes in order to meet patient's needs.
c. Responsible for implementation of novel cell therapy technologies into the GMP Laboratory which will include but not limited to scale up of procedures, design and writing of Validation Plans complete documentation of results, summary, review and approval of Validation Plans and institution of the new procedures into the GMP laboratory. Works closely with faculty and staff for seamless transition of protocols on the laboratory from initial presentation by scientific team to execution by GMP staff.
d. Preparation of budgets for clinical protocols and sponsors based on understanding of scientific processes and resources required. In addition, support the generation of the technical aspects of the CMC Document for the study. All of these components are required for patient safety and FDA inspections. Therefore attention to all details is critical.
e. 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 insure staff are trained and are able to apply knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria. Expertise in all aspects of aseptic technique is a major requirement for the position to ensure that all complex cellular cultures performed in the GMP laboratory are performed perfectly to minimize microbial contamination of the cell therapy products.
f. Serve as technical resource to staff during working and non-working hours and be on call 24 hours a day, seven days a week. Due to the critical nature of the transplant products, must respond in a timely manner after hours. Serve as mentor and coach to staff, conduct specified training if needed and review competency assessment of staff.
g. Oversee the development and completion of assigned projects that are critical to daily work in the laboratory.
h. Develops, implements, and manages an efficient, accurate and sustainable inventory management system, including supplies, reagents and equipment.
i. Manage GMP personnel
Establishes and maintains the correct skill mix and adequate numbers to maintain continuity, efficiency and high quality operations.
Develop, implement and manage staff training, development, appraisal and technical proficiency, monitoring training and competency ensuring regulatory compliance.
Participate in developing training, education, and promotion for all staff. Manages and enforces compliance with employee performance and safety guidelines, policies and procedures, according to applicable institution and state and federal agencies.
j. Work closely with Institutional Facilities to ensure the GMP facility is maintained according to FDA guidelines GTP and GMP requirements.
k. Work closely with vendors to ensure the necessary services around equipment, reagents and supplies meet all regulatory requirements
l. Must have outstanding interpersonal communication and customer service skills, excellent verbal communication skills, excellent organizational skills, attention to detail and good writing skills.
m. Manage product folders Provides adequate systems to manage, track and securely store product/patient files to meet or exceed institutional and external regulatory guidelines (FDA, FACT, and CAP).
n. Coordinate final review of product/patient folder documentation in a timely and efficient manner with Quality Assurance for release of product for transplant.

2. Novel Cell Therapy Development and Manufacturing
a. Work with faculty to develop and manufacture novel cell therapies including, mesenchymal stem cells (MSCs), NK and NK CAR, Veto Cells, CAR T-cell, and exosomes.
b. Develop and oversee a viral production facility within the GMP Laboratory. This will include helping the Directors design the GMP rooms to meet FDA guidelines, writing all new SOPs related to viral vector production, train the technologist so generate this unique product, institute a regulatory program to release the vectors for clinical use.

3. Regulatory Compliance
a. Responsible for timely communication of issues and policies to staff and to external groups that may be affected by the change.
b. Responsible for writing and revising standard operating procedures and policies ensuring compliance with current Good Laboratory Practice (cGTP) regulations and applicable accreditation agency standards, including but not limited to FDA, FACT, CAP, and CLIA. Review SOPs written by other staff and ensure their completeness and accuracy.
c. Oversee proper documentation of deviations, investigations and associated corrective actions. Participate in process improvement projects.
d. Responsible for implementing quality control testing procedures and proficiency testing programs in order to maintain regulatory compliance as well as provide patients with high quality and safe products.
e. Maintain sufficient and current knowledge of 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 such as FACT, CAP, CLIA.
f. Responsible for identifying areas affecting the laboratory procedures and policies and provide support in the inspection process. Ability to educate staff on the applicable regulatory requirements defined in policies and procedures.
g. Participate in regular meetings with senior management team coordinating and communicating effectively with peers and others to accomplish goals and ensure maximum coordination of efforts.
h. Provides timely communication of relevant information to CTL personnel and maintains communication between activities

4. Budgeting
a. Assist in the yearly forecasting budget, which will include but not be limited to defining all equipment required to perform the clinical operations and participating in the forecasting of number of procedures.

EDUCATION

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

EXPERIENCE
Required: Eight years of experience in clinical processing of cellular products with four years of supervisory or management experience in a cell therapy laboratory.
Preferred: Ten years of experience in clinical processing of cellular products with four years as supervisor or manager of Cell Therapy Laboratory.

CERTIFICATION
Required: None
Preferred: Certified Medical Technologist (MT) by the American Society of Clinical Pathologists (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

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