CTL Specialist

Children's National Hospital$61K — $102K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in basic science or related field required.
  • Master's degree in biology or related field preferred.
  • 4-5 years of experience in a clinical lab or GMP/GLP setting required.
  • 1 year of supervisory experience preferred.
  • Knowledge of cell therapy manufacturing, aseptic processing, and cell-based assays.

Responsibilities

  • Lead training for new staff members in the lab.
  • Plan and manage research projects in compliance with regulations.
  • Assist in developing and implementing new CTL protocols.
  • Conduct scientific projects related to product manufacturing or development.
  • Perform various assays including flow cytometry and immunofluorescence.
  • Manage logistics such as purchasing and shipping equipment.
  • Collaborate with teams across quality control, assurance, and scientific leads.

Benefits

  • Comprehensive benefits package (details not specified).
  • Opportunities for continuing education and training.
Full Job Description

Department
10092 Bone Marrow Transp Lab

Pay Range
$61,443.20 - $102,419.20

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. The Cellular Therapy Laboratory develops and manufactures novel cell therapy products for clinical trials and to treat patients diagnosed with otherwise incurable diseases. This position leads the training of new staff.

Minimum Education
Bachelor's Degree Bachelor's degree in basic science or a related field. (Required)
Master's Degree Master's degree in biology or a related field. (Preferred)

Minimum Work Experience
4 years 4-5 years of experience in a clinical lab or GMP/GLP setting. (Required)
1 year Supervisory experience. (Preferred)

Required Skills/Knowledge
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.

Required Licenses and Certifications
Medical Laboratory Scientist certification, MT (ASCP) (Preferred)

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.
Job Functions
  • 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.


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.

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