Laboratory Supervisor - Stem Cell (JR229010)

ViziRecruiter,LLC.; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Montefiore Medical Center's Division of Clinical Pathology seeks a Laboratory Supervisor to lead the Stem Cell (Hematopoietic) Laboratory, overseeing cryopreservation and preparation of bone marrow and peripheral blood stem cells for patient therapies.

Under the manager, duties include policy development, regulatory compliance with NYS, CAP, and Montefiore, and staff training. The role emphasizes quality assurance, budget involvement, and adoption of new technologies.

Qualifications

• Bachelor's degree required; Master's preferred.
• NYS DOE Clinical Laboratory Technologist license is required; ASCP registration or equivalent desirable.
• 4 years bench experience as CLT required (2 years could be substituted for a Master's degree).
• Experience with Miltenyi CliniMacs instrument is preferred.
• General computer knowledge: Microsoft Office and LIS.

Responsibilities

• Oversee the daily operations of the Stem Cell lab including cryopreservation, freezing and thawing of products, record review.
• Process cellular therapy according to SOP and good manufacturing practices in compliance with regulatory agencies.
• Issue cellular therapies for reinfusion to the appropriate patient per SOP and regulations.
• Monitor and ensure compliance with rules and regulations established by internal and external agencies.
• Assist manager with internal audits and provide long-term solutions to issues found.
• Develop and maintain Stem Cell Laboratory SOP manuals; monitor effectiveness.
• Educate and train Stem Cell and Blood Bank staff on processing, cryopreservation, reinfusion, quality issues and GMPs.
• Develop and implement Inventory Control; ensure quality control procedures.
• Assist with disaster control planning and equipment maintenance.
• Ensure recordkeeping complies with regulatory agencies.
• Assist with budget planning and staying current with new technology.

Skills

Laboratory leadership

Regulatory compliance

Quality management

Microsoft Office

Education

Bachelor's degree

Master's degree preferred

Tools

Miltenyi CliniMacs instrument

Job description

Introduction

To heal, to teach, to discover and to advance the health of the communities we serve.

To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here.

Overview

Montefiore Medical Center's Division of Clinical Pathology is responsible for the laboratory testing of blood, urine, and body fluids for disease diagnosis and health maintenance. Utilizing the latest advances in computer technology, the Division maintains millions of dollars of state-of-the-art automated equipment at its laboratory sites and services hospitals, nursing homes, the Montefiore Medical Group, faculty practices, and voluntary physicians' offices at more than 40 sites.

The laboratory supervisor is responsible for the daily operations of the Stem Cell (Hematopoietic) Laboratory including the cryopreservation and preparation of bone marrow and peripheral blood stem cells for patient treatments.

Under the oversight of the laboratory manager, the supervisor is responsible for writing and implementing laboratory policies, and procedures; ensures compliance with federal, NYSDOH, CAP, other regulatory accreditation agencies and Montefiore and departmental policies and procedures; interacts with other departments, Pathology leadership and staff physicians; ensures staff and customer satisfaction.

Responsibilities

• Oversee the daily operations of the Stem Cell lab such as cryopreservation, freezing and thawing of products, record review, etc.
• Process cellular therapy according to SOP and good manufacturing practices in compliance with federal, state, and any other voluntary accreditation agency.
• Issue of cellular therapies for reinfusion to the appropriate patient according to SOP and good manufacturing practices in compliance with federal, state, and any other voluntary accreditation agency.
• Monitor and ensure compliance with rules and regulations established by internal and external regulatory agencies (NYS, OSHA, CAP, etc.).
• Assist manager with continuous internal assessments of the Stem Cell Laboratory through auditing. Offer long‑term solutions to issues found.
• Develop and maintain a Stem Cell Laboratory Standard of Procedure Manuals (in cooperation with the Director and Manager). Monitor effectiveness of SOP.
• Educate, train and routinely in‑service Stem Cell and Blood Bank associates in the following (but not limited to): stem cell issue processing, cryopreservation and reinfusion of bone marrow and peripheral blood stem cells and immune effector cells, quality issues and good manufacturing practices; monitoring of freezers alarm system.
• Develop, implement and reinforce Inventory Control and assure adequacy of quality control procedures.
• Assist manager with a Stem Cell Laboratory disaster control plan and perform maintenance and delegate repair of all equipment when applicable.
• Ensure recordkeeping is in compliance to regulatory agencies.
• Help develop and maintain an adequate budget.
• Keep current with new technology. Implement when applicable.
• Assist manager with review of effectiveness of all corrective action plans.

Requirements

• Bachelor's Degree required; Master's Degree preferred.
• NYS DOE Clinical Laboratory Technologist license is required. ASCP registration or equivalent desirable.
• In order to qualify for a supervisor position, as per NYS DOE, 4 years of bench experience as CLT required (2 years could be substituted for a Master's degree in Science or Arts).
• Preferred experience with Miltenyi CliniMacs instrument for cell selection.
• General computer knowledge and software such as but not limited to Microsoft Office, LIS, ordering software, etc.
• Ability to operate general office equipment such as but not limited to computers, printers, fax machines, scanners, label printers, etc.