Manager, Cellular Therapy Laboratory Operations

New York Blood Center Inc•City of Rye, NY

4d•$132,000 - $142,000

About The Position

The Operational Laboratory Manager leads the day-to-day operation of the Comprehensive Cell Solutions department’s GTP laboratory, overseeing the safe, compliant, efficient, and high-quality manufacture and processing of cellular therapy products. The role provides leadership and supervision for laboratory staff, verifies technical procedures, manages workflows and operational performance, and performs technical work when applicable. It serves as a liaison among laboratory operations, quality, clinical teams, clients, and organizational leadership, and collaborates with departments including finance, HR, IT, and facilities. The manager oversees project and resource management, including personnel, budgets, fee schedules, equipment, materials, timelines, and work assignments. Responsibilities include evaluating potential business opportunities and procedural feasibility; adopting and transferring procedures; developing and revising SOPs, training documents, protocols, and trials; and overseeing procedure and equipment validation with laboratory and medical directors and QA. The role ensures staff training and competency, compliance with applicable regulatory and accreditation requirements, laboratory safety, quality control, accurate records, and environmental monitoring. It also supports research and collaboration, client satisfaction, quality indicators, presentations, and continuous improvement.

Requirements

Biology degree and experience in a cell therapy laboratory.
Five years of experience in cellular therapy, translational and GTP laboratories, in vitro cell culture, related analytical laboratories, or experimental and clinical trial studies.
Three years of managerial experience.
Experience writing SOPs and assessing competency.
Knowledge of cGMP, cGTP, GDP, GCP, FDA, FACT, and AABB requirements and standards.
Knowledge of cGMP laboratory and regulatory requirements and cellular therapy-related manufacturing.
Knowledge of flow cytometry and working knowledge of quality assurance tasks, including deviation management and CAPAs.
Knowledge of Microsoft Word, Excel, PowerPoint, and Visio, as well as general analytics.
Knowledge of cellular therapy literature and experience in science-based GTP manufacturing.
Cultural competency and ability to communicate effectively and sensitively with diverse individuals and groups.
Strong interpersonal, communication, presentation, and networking skills, including the ability to explain complex strategic issues clearly and logically.
Strategic thinking, detailed analysis, interpretation, and reporting skills, with practical, informed innovation.
Ability to build productive relationships with academic scientists and research and business executives in biotechnology, pharmaceutical, and medical device industries.
Ability to work in a fast-paced environment while supervising multiple projects and activities simultaneously.
Leadership qualities that inspire trust, respect, credibility, and confidence among peers and colleagues.
Ability to manage people and assign work effectively based on staff skills.
Proven ability to oversee projects, schedule progress against milestones, and develop and monitor detailed budgets.
Ability to handle pressure and ambiguity while maintaining focus in uncertain situations.

Responsibilities

Manage day-to-day GTP laboratory operations and oversee cellular therapy product manufacturing, processing, and testing.
Supervise staff, verify technical procedures, assign work based on staff skills, and perform hands-on laboratory work when applicable.
Manage workflows, calendars, work assignments, on-call coverage, emergency staffing, and evening and weekend shifts.
Evaluate the feasibility and resource needs of business proposals and requests from potential clients.
Work with laboratory and medical directors and clients to adopt new procedures and address patient care needs.
Develop trial strategies and assist with protocol development, research studies, and research protocol design or modification.
Create, develop, and revise SOPs, training documents, and procedure modifications; transfer procedures from collaborating laboratories and clients to NYBC.
Read, interpret, and implement techniques described in scientific literature, and confirm the validity of methods used at NYBC.
Oversee procedure, equipment, and protocol validation in collaboration with laboratory and medical directors and QA.
Ensure laboratory safety, equipment needs, accurate record keeping, and compliance with applicable regulatory and accreditation standards.
Manage projects by ensuring appropriate staffing, training, equipment, materials, budgets, and timelines are in place.
Identify equipment and supply needs, obtain quotes and equipment demonstrations, and prepare written purchase justifications.
Establish required quality control procedures and collaborate with internal business units to develop and report on quality indicators.
Ensure SOPs for product manufacture and testing are followed and staff are trained and competent.
Work with the Assets Management team on equipment purchasing qualification, maintenance, and documentation.
Perform environmental monitoring of the laboratory when required.
Collaborate with scientists, researchers, external laboratories, and clients to develop expertise in cellular therapy and regenerative medicine and advance NYBC’s work.
Contribute to paper and grant writing, including budget preparation and submission, and present data within NYBC and at national meetings.
Participate in committees and initiatives, recommend operational improvements, and perform related duties as assigned.