Manager, Cellular Therapy Laboratory Operations

** Responsibilities*
* The Operational Laboratory Manager is responsible for the day-to-day management and oversight of cell therapy laboratory operations to ensure the safe, compliant, efficient, and high-quality manufacture and processing of cellular therapy products. This role provides leadership for laboratory staff, manages operational performance, ensures adherence to applicable regulatory and accreditation standards, and supports continuous improvement initiatives. The Operational Laboratory Manager serves as a key liaison between laboratory operations, quality, clinical, and organizational leadership to ensure consistent delivery of cellular therapy products and services.

This position will lead laboratory operations for   the Comprehensive Cell Solutions department which includes real-time verification of technical staff procedures, project management, resource management, including personnel, project budgets and fee schedules, and performance of technical work when applicable, , workflow management, and supervision of staff.  This position contributes with innovative solutions that advance the organization's strategy and extend knowledge in the laboratory.

This position works collaboratively with other departments including finance, quality, HR, IT and facilities.

+ Manage day-to-day operation of the GTP laboratory manufacturing products. Supervise and contribute to the manufacture of cellular therapy products in the laboratory including hands on laboratory work where applicable. Work with laboratory director and/or business development to analyze business proposals and requests from potential NYBC/CCS clients to determine the feasibility of performing these procedures at NYBC.

+ Identify resources required to successfully compete for such business opportunities and to perform procedures and operations necessary.

+ Work with laboratory and medical directors and clients to adopt procedures new to the laboratory.

+ Contribute to trial development strategy and assist with protocol development.

+ Create, develop, and evaluate SOPs and training documents, etc, where applicable

+ Collaborate with external laboratories to learn procedures and methodologies that will be established in NYBC laboratories.

+ Transfer standard operating procedures from collaborating laboratories to NYBC which includes writing modifications of SOPs as appropriate to meet organizational needs.

+ Read, understand, interpret, and implement techniques described in scientific literature.

+ Oversee validation of procedures and equipment and protocols in collaboration with the lab director, medical director and QA.

+ Ensure compliance with laboratory safety guidelines; oversee equipment needs and accurate record keeping.

+ Oversee Project management including writing SOPs, ensuring staff are trained and competent to perform procedures, ensuring appropriate resources are available including personnel, equipment and materials, developing budgets, timelines and personnel.

+ Identify equipment and supply needs for each project and obtain quotes and equipment demos as necessary to evaluate equipment to be purchased.

+ Provide documentation of needs for new equipment and materials and presents with written justification for their purchase.

+ Ensure experiments and procedures at NYBC are performed to confirm validity of methods in scientific literature and /or provided by collaborators.

+ Ensure quality control procedures are established as required by FDA and other regulatory bodies.

+ Work with internal business units to identify, develop and implement appropriate quality indicators providing regular reports on the status of these indicators.

+ Work with scientists and other staff to participate in the design and modification of…