Manager, Cellular Therapy Laboratory

New York Blood Center Enterprises • Rye, NY

15h • Onsite

About The Position

This position oversees the daily operations of a cellular therapy laboratory operations of cellular therapy, ensuring quality, compliance and efficacy in the processing, cryopreservation, storage, and distribution of cellular therapy products. The primary duties include: Operations Management: Supervising day-to-day lab activities, ensuring smooth workflows, and managing resources (personnel, equipment, supplies). Quality: Assurance: implementing and maintaining quality control and quality assurance systems, validating new procedures, and ensuring compliance with regulatory standards like FACT, CLIA, and FDA. Staff Management: training and supervising laboratory personnel, including performance evaluation and competency assessments. Compliance: Ensuring adherence to all applicable regulations, including those related to safety, patient confidentiality and product handling. Inventory Management: Overseeing the inventory of supplies and reagents, equipment maintenance and calibration, and ensuring proper documentation. Technical Expertise: Providing technical guidance to staff, troubleshooting equipment issues, and participating in process validation and optimization. Communication and Collaboration: Communicating effectively with clinical teams, Medical and Laboratory Directors, ensuring proper information flow and problem resolution. Process Improvement: Assisting Lab Director on identifying areas for process improvement, developing and implementing new procedures and contributing to the continuous improvement of laboratory operations.

Requirements

• Bachelor’s or higher degree in clinical laboratory technology, or Bachelor's or higher degree from a program with a major in biology, chemistry, or the physical sciences, and an advanced certificate in clinical laboratory technology, or Education and training sufficient to qualify for licensure as a Clinical Laboratory Technologist prior to 2009 as specified in NYS-ED Regulation 79-13.4.
• Pursuant to New York Codes, Rules and Regulations, Title 10 Section 58-1.4 Qualifications of Laboratory Supervisor (c), there is no substitute for the experience criteria.
• Minimum of 5 years Cellular Therapy or Stem Cell Laboratory experience.
• 3 years managerial experience.
• Experience writing SOPs and assessing competency.
• Experience evaluating staff including discipline, hiring, firing, and annual performance appraisals.
• Relevant certifications (e.g., MT (ASCP), NYSDOH Medical Technologist license or NYSDOH Restricted license in Cellular Therapy).
• Strong understanding of cellular therapy techniques, medical terminology, regulatory requirements, quality control principles, and laboratory safety practices.
• Knowledge of medical terminology and ability to discuss patient test results and donor and product qualification of cell therapy products with patients' physicians.
• Knowledge of donor qualification requirements for Cellular Therapy products.
• Ability to maintain accurate paper and electronic records, including but not limited to patient charts, billing and coding records for procedures, staff performance appraisals, lab expenditures.
• Excellent verbal and written communication skills.
• Excellent computer skills including Microsoft Office.
• Excellent leadership, verbal and written communication and interpersonal skills.
• Ability to train and mentor staff.
• Strong problem-solving and analytical abilities.
• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse background.
• Ability to work and maintain staff morale under pressure.

Responsibilities

• Supervising day-to-day lab activities, ensuring smooth workflows, and managing resources (personnel, equipment, supplies).
• Implementing and maintaining quality control and quality assurance systems, validating new procedures, and ensuring compliance with regulatory standards like FACT, CLIA, and FDA.
• Training and supervising laboratory personnel, including performance evaluation and competency assessments.
• Ensuring adherence to all applicable regulations, including those related to safety, patient confidentiality and product handling.
• Overseeing the inventory of supplies and reagents, equipment maintenance and calibration, and ensuring proper documentation.
• Providing technical guidance to staff, troubleshooting equipment issues, and participating in process validation and optimization.
• Communicating effectively with clinical teams, Medical and Laboratory Directors, ensuring proper information flow and problem resolution.
• Assisting Lab Director on identifying areas for process improvement, developing and implementing new procedures and contributing to the continuous improvement of laboratory operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager