CTL Specialist

Children's National Hospital

7d•$61,443 - $102,419•Onsite

About The Position

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 routinely performs manual and automated cell processing, cell expansion and other assays in dedicated lab space, clean room environments or process development labs. This position leads the training of new staff.

Requirements

Bachelor's degree in basic science or a related field.
4-5 years of experience in a clinical lab or GMP/GLP setting.
Ability to lift a minimum of 50 pounds.
Ability to bend, stretch, climb ladders, stand for long periods of time, etc.
Knowledge of manufacturing cellular therapy products, aseptic processing, cell-based assays such as flow cytometry and Elispot assays and/or release testing.
Strong computer skills.
Ability to work and collaborate with others.
Ability to wear all PPE, including facemasks, lab coveralls, shoe covers and hair bonnets.
Ability to follow procedures/policies and adhere to all documentation requirements.

Nice To Haves

Master's degree in biology or a related field.
1 year Supervisory experience.
Medical Laboratory Scientist certification, MT (ASCP)

Responsibilities

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.
Communicates effectively with management for any processing, product/assay development or equipment issues.
Assists with development and implementation of new CTL protocols.
Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment and products.
Participates in the management and operation of the lab.
Demonstrates independent ability to conduct scientific projects related to product manufacturing or product development.
Performs assays such as epitope mapping, immunofluorescence and IHC in addition to release testing assays.
Handles instruments required for assays.
Takes an active part in the optimization and validation of protocols.
Performs cell manipulation/evaluation procedures such as stem cell and/or cellular product cryopreservation, cell enrichment and/or purging, cell evaluation and sorting, cell culture and cell product thaw/wash and infusion.
Performs calculations for infusion cell doses, viabilities, dilutions and cell concentrations; manages aseptic handling of products.
Performs procedures and maintains accurate documentation in compliance with regulations.
Follows procedures/policies implemented by study sponsors and adheres to all defined processing and documentation requirements.
Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Works as part of a team to execute CTL operations in close collaboration with materials management, quality control, quality assurance and scientific leads.
Willing to accept temporary responsibilities outside of initial job description.