CTL Senior Specialist
Children's National Hospital
Summary
The CTL Senior Specialist proficiently operates the majority of procedures and equipment as a subject matter expert, including cell processing, cell-based assays and tracking and evaluating laboratory test results and manufacturing milestones.
Job description
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.
Requirements
- Bachelor's degree in basic science or a related field (Required)
- Master's Degree (Preferred)
- At least 6 to 10 years of related experience (Required)
- 1 to 3 years supervisory experience (Required)
- 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
- Medical Laboratory Scientist Certification, MT (ASCP) (Preferred)
Benefits
- Comprehensive health coverage
- Medical services
- Prescription services
- Infertility services
- Transgender health services
- Paid time off
- Vacation accrual
- Sick leave
- Holidays
- Personal day
- 401(k) plan
- Healthcare spending accounts
- Dependent care spending accounts
- Employer-paid life insurance
- AD&D insurance
- Long-term disability coverage
- Tuition assistance
- Fitness resources
- Employee assistance
- Commuter benefits
Company overview
Children's National Hospital is a premier pediatric healthcare institution located in Washington, D.C., recognized as one of the top children's hospitals in the United States. Founded in 1870, it serves as the region's primary pediatric academic medical center, providing comprehensive care across all pediatric specialties. The hospital operates a 323-bed facility and offers advanced medical services including neonatal intensive care, pediatric surgery, oncology, cardiology, and neurology. As an academic medical center affiliated with the George Washington University School of Medicine and Health Sciences, Children's National is deeply involved in pediatric research, medical education, and clinical innovation. The institution is particularly renowned for its Sheikh Zayed Institute for Pediatric Surgical Innovation and its leadership in pediatric genomics and precision medicine. Children's National consistently ranks among the top pediatric hospitals nationally, with specialties in cancer, cardiology, neurology, and neonatology receiving particular recognition for excellence in patient care and outcomes.