Manager, Cellular Therapy Laboratory

About the role

This position oversees the daily operations of a cellular therapy laboratory, ensuring quality, compliance, and efficacy in the processing, cryopreservation, storage, and distribution of cellular therapy products.

Responsibilities

• Supervise day-to-day lab activities, ensuring smooth workflows, and manage resources (personnel, equipment, supplies).
• Implement and maintain quality control and quality assurance systems, validate new procedures, and ensure compliance with regulatory standards like FACT, CLIA, and FDA.
• Train and supervise laboratory personnel, including performance evaluation and competency assessments.
• Ensure adherence to all applicable regulations, including those related to safety, patient confidentiality, and product handling.
• Oversee inventory of supplies and reagents, equipment maintenance and calibration, and ensure proper documentation.
• Provide technical guidance to staff, troubleshoot equipment issues, and participate in process validation and optimization.
• Communicate effectively with clinical teams, Medical and Laboratory Directors, ensuring proper information flow and problem resolution.
• Assist the Lab Director in identifying areas for process improvement, developing and implementing new procedures, and contributing to the continuous improvement of laboratory operations.
• Maintain accurate paper and electronic records, including patient charts, billing and coding records, staff performance appraisals, and lab expenditures.

Requirements

• Bachelor’s or higher degree in clinical laboratory technology, or a 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.
• 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.
• Minimum of 5 years of Cellular Therapy or Stem Cell Laboratory experience.
• 3 years of managerial experience.
• Experience writing SOPs and assessing competency.
• Experience evaluating staff, including discipline, hiring, firing, and annual performance appraisals.

Qualifications

• 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 donor qualification requirements for Cellular Therapy products.
• Ability to discuss patient test results and donor and product qualification of cell therapy products with patients' physicians.
• Excellent verbal and written communication skills.
• Excellent computer skills, including Microsoft Office.

Skills

• 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 individuals and groups from diverse backgrounds.

Pay

For applicants who will perform this position in Westchester County, the proposed annual salary is $140,635.00 to $150,050.00 per year. For applicants outside of New York City or Westchester County, salary will reflect local market rates.