Overview In this role you support translational development and clinical production of novel cell therapies within the Translational Area. You will act as a technical resource and problem-solver, guiding CT staff and overseeing quality, documentation, and equipment qualification. You'll coordinate development plans, validation, and assay work while ensuring data integrity and regulatory alignment. This is an opportunity to shape cutting-edge cell therapy programs and collaborate across departments on high-impact translational work.
Compensation / Benefits- medical, dental, vision plans
- life insurance
- PTO and sick time
- tuition reimbursement
- retirement plan
- short-term and long-term disability
Responsibilities- Coordinate product development, validation plans, and assay development for cell therapies
- Oversee QC testing (flow cytometry, bioburden, cell enumeration, viability, potency) and maintain documentation (batch records/SOPs)
- Manage vendor/equipment qualifications, project timelines, and staff training
- Provide guidance, training, and troubleshooting support to CT staff
- Direct daily task management, workload assignment, and performance input
- Ensure accurate data entry, investigate deviations, and contribute to regulatory and project reports
- Maintain and troubleshoot laboratory equipment and coordinate service for manufacturer equipment
- Support continuous process improvement and cross-functional collaboration
Key requirements- Baccalaureate or higher degree in a related laboratory field with CLIA qualifications as general supervisor for high complexity testing or technical consultant for moderate complexity testing
- Degree options include B.S. in chemical, biological, clinical or medical laboratory science, or medical technology; or M.S. in related fields meeting CLIA qualifications
- 1-2 years of laboratory experience in high or moderate complexity testing depending on degree, or equivalent training for supervisor/consultant roles
- Possession or eligibility for appropriate DHHS-approved laboratory certification
- Licensing/certification pathways specify MLS/MT with ASCP/ASCPi/AMT variants across labs
- Clear written and oral communication
- Teamwork and cross-department collaboration
- Problem solving and adaptability
- Flow cytometry
- Bioburden testing
- Cell enumeration and viability assays
