CTL Senior Specialist

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

Minimum Work Experience
At least 6 to 10 years of related experience. 

(Required)
1 to 3 years supervisory experience. (Required)

Required Skills/Knowledge
Knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
Expertise in cell-based assays such as flow cytometry and ELISpot, and proficiency in analysis software such as FlowJo and Prism.
Ability to troubleshoot problems and provide solutions.
Ability to review records of clinical manufacturing or process development studies.

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
 

• Finds opportunities for improvement in manufacturing efficiencies and compliance.

• Helps to identify potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them.

• Actively participates in new protocol implementation.

• Assists with investigations/ deviations and change controls, independently set up optimized procedures or new assays in the process development labs.

• Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control.

• Assists in scheduling appointments with outside vendors and equipment maintenance.

• Supervises or 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, cell product thaw/wash and infusion.

• Supervises or performs calculations infusion cell doses, viabilities, dilutions and cell concentrations.

• Maintains aseptic handling of products.

• Performs procedures and maintains accurate documentation in compliance with the regulations.

• Follows procedures/policies implemented by study sponsors and adheres to all defined processing and documentation requirements.