CTL Specialist

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.
• Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

• Demonstrate collaborative and respectful behavior

• Partner with all team members to achieve goals

• Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance