CTL Lead

Children's National Hospital; Washington (District of Columbia); On-site; USD 78,000 - 129,000; Full time

Job summary

Children’s National Hospital seeks a Cellular Therapy Laboratory Lead to oversee development, validation, and manufacturing of novel cell therapies for clinical trials and INDs. You will coordinate quality, regulatory documentation, and project management across GMP/GTP environments.

The role requires expertise in cell-based assays, data analysis, and staff supervision, with duties spanning process development, product release, and SOP maintenance in a clinical setting.

Qualifications

• Bachelor's degree in basic science or related field required.
• Ph.D. preferred for advanced translational work.
• Minimum 4 years of cell therapy or cell transplant experience with BS/MT.
• 2 years' experience with a PhD in translational research laboratory required.
• Supervisory experience desired.

Responsibilities

• Lead quality program activities and ensure regulatory compliance.
• Coordinate project schedules, testing, and data analysis for clinical trials.
• Oversee manufacture and release of cell therapy products for clinical use.
• Maintain SOPs, document controls, and participate in audits and inspections.
• Mentor junior staff and coordinate training within the team.

Skills

Cell therapy experience

Leadership

Data analysis

Education

Bachelor's degree in basic science or related field

Ph.D. preferred

Tools

Flow cytometry

Elispot

FlowJo

Prism

Job description

111 Michigan Avenue NorthwestWashington, DC 20010Kids Are Our Everything.Department10092 Bone Marrow Transp LabPay Range$77,584.00 - $129,292.80The 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.Minimum EducationBachelor's Degree Basic science or related field (Required)Doctor of Philosophy (Ph.D.) (Preferred)Minimum Work Experience4 years With BS or MT, cell therapy or cell transplant experiences (Required)2 years With PhD, working in translational research laboratory (Required)1 year Supervisory experience desired (Preferred)Required Licenses and CertificationsLaboratory Scientist Certification, MT (Required)Functional AccountabilitiesResponsible 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 staffAssist the Manager in overseeing the progression and growth of the technical staffAssist in the upkeep, maintenance and review of all manufacturing documentation and databases, schedules, etc.Assist in and provide input to critical process decisionsProvide 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 toexternal 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 reportsvariances 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 bodiesParticipate 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.The disclosed salary range includes the minimum and maximum rates within which Children’s National believes an individual’s base pay rate will fall for this position. It is not typical for an individual to be hired at or near the maximum of the pay range. The exact pay rate for this position will be based on a variety of factors in alignment with the Children’s National compensation philosophy. These factors are legitimate and non-discriminatory including, but not limited to, the current market conditions; organizational needs; the individual’s combination of prior work experience, level of education, knowledge, skills, and other qualifications. Children’s National is committed to providing a fair and competitive total rewards package to each of our employees. This base salary range does not include our comprehensive benefits package or any additional compensation for which this position may be eligible.Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The “Know Your Rights” poster is available here: and the pay transparency policy is available here: Know Your RightsPay Transparency Nondiscrimination Poster.Please note that it is the policy of Children's National Hospital to ensure a “drug-free” work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children's National and its affiliates maintain the right, in accordance with our policy, to enforce a drug-free workplace, including prohibiting recreational or prescribed marijuana.