This position is responsible for the accurate and efficient performance of all work assignments in the Human Applications Laboratory (HAL) in support of the Bone Marrow Transplantation and Cellular Therapy (BMTCT) and other institutional programs. The successful candidate will be responsible for managing personnel and work flow for the production of cellular products. They will also be responsible for the development of new procedures to support PI-initiated clinical protocols and interacts productively with facility Medical Director, faculty, staff of the BMTCT Program, GMP Facility, and Blood Donor Center/Pathology. They will work with the Department of Therapeutics Production and Quality on the development and the transition of current good tissue practice and good manufacturing practice (cGTP/cGMP) cellular products into or from cGMP manufacturing. Working with the Director of Quality Assurance, this position will ensure compliance with cGMP regulations Code of Federal Regulations Title 21(21 CFR) part 210 and 211, current good tissue practice (cGTP) regulations (21 CFR part 1271), Foundation for the Accreditation of Cellular Therapies (FACT), and other regulatory standards.
1. Serves as Director of the Human Applications Lab (HAL) and is responsible for all work performed.
a) Maintains scientific and technological expertise appropriate for the mission of the HAL, including extensive knowledge and expertise in the preparation of cellular products for clinical applications.
b) Maintains laboratory operations and capabilities at forefront of discipline.
c) Manages the day-to-day activities of the laboratory and is actively involved in reviewing and improving operational procedures in the laboratory. Analyzes workflow and recommends and implements methods for effective and efficient operation.
d) Supervises appropriate completion of all components of laboratory operation including: standard operating procedures, validation procedures, document control and record keeping, reports of adverse reactions, accidents, deviations/variances and corrective action plans and assay development and validation.
2. Ensures compliance with all applicable quality standards
a) Maintains a comprehensive understanding of cGMP regulations (21 CFR part 210 and 211), cGTP regulations (21 CFR part 1271), and FACT and other applicable regulatory standards.
b) Work closely with the Director of Quality Assurance and the Program Director of BMTCT to ensure regulatory compliance.
c) Prepares reports and materials for submission to regulatory agencies.
d) Maintains accurate section records and oversees performance of all quality control procedures.
e) Conducts or supports audits, assessments, and reviews to verify laboratory activities meet accepted standards.
f) Initiates process improvement plans to optimize laboratory performance, operational efficiency, and improve batch records and Standard Operating Procedures (SOP).
g) Participates in the Bone Marrow Transplantation Quality Assurance/Quality Improvement Committee and Quality initiatives.
3. Oversees acquisition and maintenance of laboratory equipment
a) Evaluates and recommends purchases of new equipment/instruments as necessary.
b) Assures that preventative maintenance is performed.
4. Supports research mission of institution through facility activities
a) Interacts with Medical Director and Faculty of the Bone Marrow Transplant and Cellular Therapy Program and the Quality Assurance Director on the development of new processes and procedures for clinical protocols.
b) Works in conjunction with faculty to support research opportunities within context of role. Attends and presents at national and international meetings as appropriate.
5. Supervises employees and is responsible for management and personnel structure of the laboratory.
a) Defines and communicates expectations to employees. Monitors and evaluates employee performance, including suggestions to and education of employees when necessary to ensure employee performance is satisfactory. Counsels and disciplines employees as necessary.
b) Ensures competency of staff members in the conduct of all duties.
c) Educates and advances technical expertise of the staff, ensuring that all employees are knowledgeable in applicable technologies and skills.
d) Promotes a positive work environment, culture of quality and excellence, and overall team effort.
e) Reviews work assignment schedules, and vacation/holidays.
6. Responsible for laboratory financial integrity
a) Prepares and monitors the annual budget.
b) Reviews procedure charges to ensure accurate billing.
7. Performs other related duties as assigned to meet the goals of the department and institution.
8. Maintains regular and predictable attendance.
SPECIAL SKILLS, KNOWLEDGE AND ABILITIES:
1. Meets FACT requirements for Processing Facility Director.
2. Ability to exercise good problem solving skills.
3. Ability to communicate effectively.
4. Excellent organizational skills.
5. Ability to utilize computerized databases.
6. Ability to utilize basic computer skills, including Word, PowerPoint and Excel.
7. Familiarity with regulations applicable to Cell Processing, Cell Culture and Vector Production.
8. Willingness to gain technical and biological knowledge of Cell Processing, Cell Culture and Vector Production.
9. Must exhibit strict compliance with dress restrictions for certain areas of the laboratory.
10. Extensive knowledge of laboratory procedures with specific knowledge of cell handling procedures and FACT standards.
11. Knowledge of hematopoietic stem cell processing essential.
12. Ability to supervise others and communicate effectively.
Ph.D. in a related field.
Seven (7) years of related experience that must include the following: Five (5) years in a GMP lab of five years of postdoctoral experience with at least two (2) years in a cell processing facility required. Two (2) years of supervisory experience required.
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