Cell Therapy Flow Cytometry Specialist

Summary Statement

The Cell Therapy Flow Cytometry Specialist will provide highly skilled expertise in flow equipment operation and maintenance in the cell therapy team. The flow specialist will train cell therapy personnel in the operation/ maintenance of cutting-edge flow equipment and oversee the usage of this equipment. The flow specialist will provide extensive consultation and training to team members regarding experimental design, methodology, instrument capabilities, troubleshooting, routine data analysis, and complex data analysis. The flow specialist will stay up to date in new flow cytometry techniques and methods, instrumentation, and analysis practices/platforms and incorporate best practices as appropriate in a fast-paced work environment and complete all flow operations in a timely and highly accurate manner.

Responsibilities

• Operate CytoFLEX and other cell therapy flow cytometers.
• Perform troubleshooting and schedule repairs of Flow Cytometry equipment.
• Provide technical and scientific support to the cell therapy team in operating flow equipment and Flow Analysis software (FlowJo).
• Perform and coordinate daily startup/shutdown/cleaning/maintenance of cell therapy flow equipment.
• Support manufacturing by coordinating and performing required flow testing.
• Troubleshoot flow issues related to cell therapy products.
• Work closely with QA if flow deviations occur.
• Coordinate flow testing required for cell therapy operations in ISO7 suites.
• Write SOPs related to flow cytometry for the cell therapy team.
• Provide support during audits that involve cell therapy flow testing.
• Assist in Research and Development programs coordinated by senior staff, and learn how to coordinate these programs independently.
• Adhere to GMP/GDP/GTP guidelines.
• Communicate effectively with other teams
• Other duties and procedures as assigned (cell processing and cryopreservation)
• Be involved in research projects with collaborators

Knowledge, Skills, and Experience

• Experience in cGMP and cGTP requirements.
• Understanding of applicable FDA regulations, AABB cellular therapy standards, and other relevant regulatory and accreditation requirements.
• Experience in cell and gene therapy.
• Experience in flow cytometry assays.
• Experience in flow data analysis. 
• Experience with multi-parameter flow cytometry with complex data in the cell therapy field.
• Knowledge of sterile techniques required for cellular therapy product handling and manipulation.
• Knowledge of use of liquid nitrogen, to provide a safe, compliant, and cost-effective cryogenic environment.
• Demonstrate ability to perform standard data analysis and calculations required by flow testing.
• Demonstrate ability to make independent decisions within established parameters.
• Demonstrate ability to prioritize required duties and responsibilities.
• Excellent oral and written communication skills.
• Strong organizational skills with attention to detail.
• Ability to work both independently and within teams.
• Time management skills.
• Flexibility to adjust to changes in schedules, working hours and procedures. Position may require extended hours at intervals.

Ability to work high stress situations.