The Cellular Therapy Laboratory develops and manufactures novel cell therapy products for clinical trials and to treat patients diagnosed with otherwise incurable diseases. The Cellular Therapy Lead will perform 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). These cell therapies include but are not limited to: Mesenchymal Stromal Cells, anti-viral T cells, and anti-tumor T cells. The individual will coordinate the Quality aspects of the program, to include shipment of blood or cell therapy products as well as applicable regulatory documentation, manufacture the products according to applicable regulations and accrediting agency standards. The individual will also manage the process development projects, manufacturing expectations, environment, and scheduling for a clinical trial(s), train new/current staff on procedures, assist in the release of products for clinical use, cell based assay data analysis and review, and write and review standard operating procedures. The CTL Lead will need expertise in performing cell based assays and data analysis. The individual will work primarily under the supervision of the facility director, the facility manager and the laboratory medical directors, but will interact with research staff in the pre-clinical GLP laboratory on projects. The CTL Lead will also share its time between the process development labs and the GMP facility to optimize processes and prepare new clinical manufacturing protocols. Process development activities will require extensive expertise in cell-based assays such as flow cytometry and Elispot, and proficiency in analysis software such as FlowJo and Prism; as well as ability to interact with scientific team involving PIs and potential industry partners.
Bachelor's Degree Basic science or a related field. (Required)
Doctor of Philosophy (Ph.D.) (Preferred)
Minimum Work Experience
4 years with BS or MR, cell therapy or cell transplant experiences (Required)
2 years with PhD, working in translational research laboratory. (Required)
1 year Supervisory experience desired. (Preferred)
Laboratory Scientist Certification, M.T. (Required)
Responsible Conduct of Research 10%
* Consistently demonstrate adherence with the standards of the responsible conduct of research.
* Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator.
* Responsible for appropriate use of research funds and resources.
* Comply with all annual job-related training requirements.
Project Management 30%
* Assist with planning and coordinating specific research protocols and procedures.
* Coordinate schedules of tests and procedures efficiently.
* Assist in the development and troubleshooting of new techniques and ideas.
* Maintain a log of work performed according to specific standards, compiles and helps with analyze data.
* Prepare chart, graphs, and results of studies.
* Maintain all required records, reports, statistics, etc. according to SOP, P&P and regulatory requirements.
* Deputize for the Quality and Production managers responsibilities where required in their absence.
* Assist in supervision and mentorship of junior staff
* Assist the Manager in overseeing the progression and growth of the technical staff
* Assist in the upkeep, maintenance and review of all manufacturing documentation and databases, schedules, etc.
* Assist in and provide input to critical process decisions
* Provide confidence, stability, leadership, and guidance to the manufacturing group, particularly when unscheduled or unplanned events occur.
Quality Control 30%
* Lead and maintain the Quality aspect of the program and ensure compliance.
* Undertake validation studies of processes and equipment as required.
* Ensure compliance with applicable laws and regulations (FDA, FACT, etc.).
* Coordinate interactions and shipments with outside institutions and ensures that critical samples are safely delivered to
* external facilities per SOPs.
* Manage the timely testing and release of cell therapy products for clinical use.
* Produce and review technical documentation (SOP's, MPDs, etc.) as part of the laboratories quality system and reports
* variances to facility director or manager in a timely manner.
* Maintain and update department policies regarding procedures, objectives, safety etc.
* Fully participate in internal / external audits and inspections by regulatory bodies
* Participate in the development of company-wide training programs, lab operations, and maintenance processes which are necessary to ensure cGMP compliance.
Laboratory Work 20%
* Perform standard operating policies & procedures (SOP's) and novel technology transfer processes, including state of the art techniques developed in cell culture, flow cytometry and arrangement of biological assays under direction of the facility director or manager.
* Record and check results for completeness and accuracy.
* Compile information from lab notebooks and journals.
* Refer lab equipment for preventive and routine maintenance as requested.
* Set up, clean and perform routine maintenance checks on laboratory equipment.
* Prepare materials and reagents as required.
* Order equipment & consumables and perform 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 record/transcribe and communicate translational & GxP procedures.
* Carry out regular facility cleaning, monitoring and disposal of waste.
Professional Development 10%
* Conduct literature search as directed.
* Prepare summary reports as requested.
* Attend lab seminars to further research knowledge.
* Attend courses, seminars, and lab meetings to expand knowledge of research and laboratory techniques.
* Maintain continuous education.
- Biochemical Assays
- Cell Therapy
- Clinical Trials
- Clinical Works
- Coaching And Mentoring