Location
Washington, DC, United States
Posted on
Feb 21, 2022
Profile
Description
The Cellular Therapy Laboratory (CTL) Lead develops and manufactures novel cell therapy products for clinical trials and for the treatment of patients diagnosed with otherwise incurable diseases. The CTL Lead divides time between the process development labs and the GMP facility to optimize processes and prepare new clinical manufacturing protocols. The CTL Lead works primarily under the supervision of the facility director, facility manager and laboratory medical directors, but will also work with research staff in the pre-clinical GLP laboratory on projects.
Qualifications
Minimum Education
Bachelor's Degree Basic science or a related field. (Required)
Doctor of Philosophy (Ph.D.) (Preferred)
Minimum Work Experience
4 years working in cell therapy or cell transplant environment, with B.S. or M.T. (Required) Or
2 years working in translational research laboratory, with Ph.D. (Required)
1 year Supervisory experience. (Preferred)
Required Skills/Knowledge
Expertise in performing cell-based assays, such as flow cytometry and Elispot.
Proficiency in analysis software such as FlowJo and Prism.
Ability to interact with a scientific team that includes PIs and potential industry partners.
Required Licenses and Certifications
Laboratory Scientist Certification, M.T. (Required)
Functional Accountabilities
Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
Meets all annual job-related training and compliance requirements.
Project Management
Manages process development projects, manufacturing expectations, environment and scheduling for clinical trials.
Assists with planning and coordinating specific research protocols and procedures.
Coordinates schedules of tests and procedures efficiently.
Assists in the development and troubleshooting of new techniques and ideas.
Maintains a log of work performed according to specific standards.
Compiles data and helps with analysis.
Prepares charts, graphs and results of studies.
Maintains all required records, reports, statistics, etc. according to SOP, P&P and regulatory requirements.
Deputizes for the Quality and Production managers responsibilities where required in their absence.
Assists in supervision and mentorship of junior staff.
Trains new/current staff on procedures.
Assists the manager in overseeing the progression and growth of technical staff.
Assists in the upkeep, maintenance and review of all manufacturing documentation and databases, schedules, etc.
Assists in and provides input to critical process decisions.
Assists in the release of products for clinical use and cell-based assay data analysis and review.
Provides confidence, stability, leadership and guidance to the manufacturing group, particularly when unscheduled or unplanned events occur.
Quality Control
Leads and maintains the quality aspect of the program and ensures compliance.
Undertakes validation studies of processes and equipment as required.
Ensures compliance with applicable laws and regulations (FDA, FACT, etc.)
Coordinates interactions and shipments with outside institutions and ensures that critical samples are safely delivered to external facilities per SOPs.
Coordinates applicable regulatory documentation for shipments of blood or cell therapy products.
Manages the timely testing and release of cell therapy products for clinical use.
Produces and reviews technical documentation (SOPs, MPDs, etc.) as part of the laboratory's quality system and reports variances to facility director or manager in a timely manner.
Maintains and updates department policies regarding procedures, objectives, safety, etc.
Fully participates in internal/external audits and inspections by regulatory bodies.
Participates in the development of company-wide training programs, lab operations and maintenance processes necessary to ensure cGMP compliance.
Manufactures products according to according to applicable regulations and accrediting agency standards.
Laboratory Work
Performs SOPs and novel technology transfer processes, including the state-of-the-art techniques developed in cell culture, flow cytometry and arrangement of biological assays under the direction of the facility director/manager.
Performs a variety of protocol development, process development studies, product validations, and cellular therapy product manufacturing, to include novel cellular therapy products for FDA-approved investigational new drug (IND) applications using Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP); cellular therapies include Mesenchymal Stromal Cells, anti-viral T cells and anti-tumor T cells.
Records and checks results for completeness and accuracy.
Compiles information from lab notebooks and journals.
Refers lab equipment for preventative and routine maintenance as requested.
Sets up, cleans and performs routine maintenance checks on laboratory equipment.
Prepares materials and reagents as required.
Orders equipment and consumables and performs routine stock checks to maintain levels of critical stock, as well as to communicate with suppliers and source new consumables/equipment as required.
Clearly and accurately records/transcribes and communicates translational and GxP procedures.
Carries out regular facility cleaning, monitoring and waste disposal.
Professional Development
Conducts literature search as directed.
Prepares summary reports as requested.
Attends lab seminars to further research knowledge.
Attends courses, seminars and lab meetings to expand knowledge of research and laboratory techniques.
Maintains continuous education.
Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
Anticipate and responds to customer needs; follows up until needs are met
Teamwork/Communication
Demonstrate collaborative and respectful behavior
Partner with all team members to achieve goals
Receptive to others' ideas and opinions
Performance Improvement/Problem-solving
Contribute to a positive work environment
Demonstrate flexibility and willingness to change
Identify opportunities to improve clinical and administrative processes
Make appropriate decisions, using sound judgment
Cost Management/Financial Responsibility
Use resources efficiently
Search for less costly ways of doing things
Safety
Speak up when team members appear to exhibit unsafe behavior or performance
Continuously validate and verify information needed for decision making or documentation
Stop in the face of uncertainty and takes time to resolve the situation
Demonstrate accurate, clear and timely verbal and written communication
Actively promote safety for patients, families, visitors and co-workers
Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
Primary Location
District of Columbia-WASHINGTON
Work Locations
Sheikh Zayed Campus
111 Michigan Avenue
Washington
20010
Job
Research
Organization
Ctr Cancer & Immunology Rsrch
Regular / Temporary
R (Regular)
Position Status
FT - Full-Time
Shift
Day
Work Schedule
9:00-5:30
Job Posting
Feb 18, 2022, 9:29:54 PM
Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities.
Company info
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