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.

Education:

• 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.

Related Experience:

• 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.

Licenses:

• Relevant certifications (e.g., MT (ASCP),
• NYSDOH Medical Technologist license or NYSDOH Restricted license in Cellular Therapy. (required)

Knowledge:

• 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.

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 both individuals and groups from diverse background.

Abilities:

• To play a crucial role in ensuring the quality and safety of cellular therapy products, contributing to the success of patient treatment and the advancement of this rapidly evolving field, to work and maintain staff morale under pressure.

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 who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience