Manager, Cellular Therapy Laboratory Operations

About the role

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.

Responsibilities

• 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 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, including 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 present 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 research protocols, stay current with relevant literature, and contribute to paper- and grant-writing as necessary including assistance with budget preparation and submission.
• Collaborate with other researchers within NYBC as well as external collaborators to further develop expertise in the fields of Cell Therapy/Regenerative Medicine and related work to advance NYBC.
• Communicate with clients to ensure client satisfaction with NYBC services.
• Work with clients and laboratory director to implement new/different procedures dictated by patient care needs.
• Manage calendar of procedures and work assignments, including on-call, emergency staffing, evening and weekend shifts.
• Ensure SOPs for product manufacture and testing are followed.
• Work with the Assets Management team to ensure compliance in equipment purchasing qualification, maintenance and documentation.
• Perform environmental monitoring of the lab when required.
• Present data within NYBC and at national meetings.
• Provide oversight of GTP lab processes.
• Write SOPs, technology transfer from clients and for manufacturing and testing cellular therapy products.
• Train technical staff where applicable.
• Complete various protocols and research studies.
• Participate on committees and in initiatives as necessary.
• Make recommendations to improve business unit operations.

Qualifications

Education

• Biology degree with experience in a cell therapy lab.

Experience

• 5 years in cellular therapy/translational and GTP labs, in vitro cell culture, related analytical labs, experimental and clinical trials studies.
• 3 years managerial experience.
• Experience writing SOPs and assessing competency.

Knowledge

• Knowledge of cGMP, cGTP, GDP, GCP, FDA, FACT, and AABB.
• Knowledge of cGMP laboratory and regulatory requirements.
• Knowledge of cellular therapy related manufacturing.
• Knowledge of flow cytometry.
• Working knowledge of quality assurance tasks including deviation management, CAPAs, etc.
• Knowledge of Microsoft Suite (Word, Excel, PowerPoint, Visio) and general analytics.
• Knowledge of cellular therapy literature, experience in science-based GTP manufacturing, demonstrated innovative thinking.

Skills

• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• Well-developed interpersonal skills; experienced communicator, ability to provide clear and logical presentations of complex strategic issues.
• Strategic thinking: innovating with informed, sharp and objective practical purpose, experienced in detailed analysis, interpretation and reporting.
• Strong interpersonal skills and networking.
• Ability to develop productive relationships with academic scientists and research/business executives in the biotechnology, pharmaceutical and medical device industries.
• Resilient, energetic and enthusiastic, responding constructively to challenging new ideas and inputs.

Abilities

• Ability to work in a fast-paced environment supervising multiple projects and activities simultaneously.
• Possess personal leadership qualities that inspire trust, respect, credibility and confidence of peers and colleagues and takes the organization to a higher level.
• Ability to manage people and to assign work effectively based on staff skills.
• Proven ability to maintain effective oversight of a project and schedule progress to predetermined milestones, experience in developing and monitoring detailed budgets.
• Able to handle pressure and ambiguity – comfortable with the pressure to excel and ability to maintain focus in situations of ambiguity and uncertainty.

Pay

For applicants who will perform this position in Westchester County, the proposed annual salary is $132,000.00 to $142,000.00 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.