Cellular Therapy Laboratory (CTL) Specialist

Location
Washington, District of Columbia-Washington
Posted
Feb 10, 2021
Closes
Mar 17, 2021
Ref
210000CA
Function
Nurse
Industry
Healthcare
Hours
Full Time
The Cellular Therapy Laboratory develops and manufactures novel cell therapy products for clinical trials and to treat patients diagnosed with otherwise incurable diseases. The CTL Specialist will routinely perform manual and automated cell processing, cell expansion and other assays in dedicated lab space, clean room environments, or process development labs and will lead the training of new staff. They are required to have at least 5 years of experience in clinical lab or GMP/GLP setting and a confirmed knowledge of manufacturing cellular therapy products, aseptic processing, cell-based assays such as flow cytometry and Elispot assays, and/or release testing.

Qualifications

Minimum Education
Bachelor's Degree
Master's Degree

Specific Requirements and Preferences
Basic Science or related field (Required)
Biology or related field (Preferred)

Minimum Work Experience
4 years
1 year

Specific Requirements and Preferences
Related experience (Required)
Medical Laboratory Scientist Certification, MT (ASCP) desired (Preferred)
Supervisory experience (Preferred)

Functional Accountabilities

Job Functions
1. Communicate effectively with management for any processing, product/assay development or equipment issues.
2. Assists with development and implementation of new CTL protocols. Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment and products.
3. Participates in the management and operation of the lab, show independent ability to conduct scientific projects related to product manufacturing or product development. Willing to accept temporary responsibilities outside of initial job description.
4. In addition to release testing assays, perform assays such as epitope mapping/ immunofluorescence/ IHC and be able to handle instruments required for the assays.
5. Take an active part in optimization and validation of protocols.
6. Performs cell manipulation/evaluation procedures such as stem cell and/or cellular product cyropreservation, cell enrichment and/or purging, cell evaluation and sorting, cell culture, cell product thaw/wash and infusion.
7. Performs calculations infusion cell doses, viabilities, dilutions and cell concentrations. Responsible for aseptic handling of products.
8. Performs procedures and maintains accurate documentation in compliance with the regulations.
9. Follows procedures/policies implemented by study sponsors and adheres to all defined processing and documentation requirements.
10. Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
11. Meets physical requirements: be able to lift a minimum of 50 pounds; ability to bend, stretch, climb ladders, stand for long periods of time, etc.
12. Must have computer skills.
13. Must be able to work and collaborate with others.
14. Must be able to wear all PPE including but not limited to facemasks, lab coveralls, shoe covers, and hair bonnets.
15. Must be able to follow procedures/policies and adhere to all documentation requirements.
16. Work as part of a team to execute CTL operations in close collaboration with Materials Management, Quality Control, Quality Assurance and Scientific Leads.

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.

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