Associate Director- Cell Therapy Lab

New York Blood Center Enterprises•Rye, NY

1d•$160,000 - $170,000

About The Position

The Associate Director 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. This includes staff management, training, quality assurance, and adherence to regulatory requirements. The Associate Director with work closely with the Cell Therapies Lab Director in creating standard operating procedures (SOPs), project management, resource management, including personnel, have oversight of project budgets and fee schedules, performance of experimental work, development and implementation of experimental protocols, workflow, and supervision of staff, as well as additional duties as required. This individual will work closely with leadership of corresponding cGMP and other CCS laboratory teams, as well as clinical apheresis services, business development and others as necessary. The director is expected to understand and be aware of the trends of the clients and service portfolios under the prevue of this position and help to foster relationships. This individual will be expected to participate in client meetings, off-site activities/events, and meetings. Tracking of projects timelines and trending data will be required. Supervising day-to-day lab technical activities, ensuring smooth workflows, and managing resources (personnel, equipment, supplies). Implement and maintain quality control and quality assurance systems, validating new procedures, and ensuring compliance with regulatory standards like FACT, CLIA, and FDA. Manage, train and supervise laboratory personnel, including performance evaluation and competency assessments. Ensure adherence to all applicable regulations, including those related to safety, patient confidentiality and product handling. Oversee the inventory of supplies and reagents, equipment maintenance and calibration, and ensuring proper documentation in collaboration with the assets and materials management team. Provide technical guidance to staff, troubleshoot equipment issues, and participate in process validation and optimization. Communicate effectively with clinical teams, Medical and Laboratory Directors, ensure proper information flow and problem resolution. Assist the Lab Director on identifying areas for process improvement, develop and implement new procedures and contributing to the continuous improvement of laboratory operations. Ensure projects are completed in a timely fashion. Oversee new products and services. Participate in initiatives that increase visibility and grow new business, including conferences, publications, and other types of outreach. Evaluate new and emerging technologies and makes recommendations bases on these evaluations. Identify and implement quality indicators and provides regular reports on the status of these indicators. Provide effective customer service by partnering with internal business units to resolve customer issues. Work as an individual or on a team for assigned special projects. Make recommendations for improvement of practices in assigned business units. Attend professional development seminars, conferences and meetings as required. Any related duties as assigned.

Requirements

Doctorate degree in Biology or equivalent field of science, or MD.
Seven years’ experience in a clinical laboratory setting which should include experience in a hematopoietic laboratory or a flow cytometry laboratory or equivalent.
Meet NYSDOH requirements for Stem Cell Laboratory Director.
Expert knowledge in practices and procedures in cellular therapy, flow cytometry, processing.
Knowledge of various computer software applications (MS Office Suite), MES or LIMS.
Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
High level of interpersonal skills to handle a variety of complex issues and situations.
Position requires demonstrated poise, tact and diplomacy in dealing with a variety of staff up to and including executive leadership.
Strong attention to detail in all research and work processes.
Ability to conduct research on various topics.
Ability to work independently with minimal supervision.
Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings.
Ability to interact with individuals at all levels of the organization and customers in a helpful, courteous and friendly manner while demonstrating sensitivity to and respect for diverse populations.
Ability to work in a strong team environment.
Ability to plan and organize job tasks or resources in an efficient manner.
Ability to be responsive and available to management in order to address issues and concerns as they arise.
Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
Ability to use logic and reasoning to identify and analyze the strengths and weaknesses of alternative solutions, conclusions or approaches to problems within established policies and procedures.
Ability to identify complex problems in a timely manner, decipher information to develop and evaluate options and implement solutions.
Ability to handle and work with sensitive and confidential information and maintain confidentiality.
Any combination of education, training and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

Nice To Haves

Certificate of Qualification for Flow Cytometry preferred
New York State Lab Technologist License preferred.

Responsibilities

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.
Staff management, training, quality assurance, and adherence to regulatory requirements.
Creating standard operating procedures (SOPs), project management, resource management, including personnel, have oversight of project budgets and fee schedules, performance of experimental work, development and implementation of experimental protocols, workflow, and supervision of staff, as well as additional duties as required.
Work closely with leadership of corresponding cGMP and other CCS laboratory teams, as well as clinical apheresis services, business development and others as necessary.
Understand and be aware of the trends of the clients and service portfolios under the prevue of this position and help to foster relationships.
Participate in client meetings, off-site activities/events, and meetings.
Tracking of projects timelines and trending data will be required.
Supervising day-to-day lab technical activities, ensuring smooth workflows, and managing resources (personnel, equipment, supplies).
Implement and maintain quality control and quality assurance systems, validating new procedures, and ensuring compliance with regulatory standards like FACT, CLIA, and FDA.
Manage, train and supervise laboratory personnel, including performance evaluation and competency assessments.
Ensure adherence to all applicable regulations, including those related to safety, patient confidentiality and product handling.
Oversee the inventory of supplies and reagents, equipment maintenance and calibration, and ensuring proper documentation in collaboration with the assets and materials management team.
Provide technical guidance to staff, troubleshoot equipment issues, and participate in process validation and optimization.
Communicate effectively with clinical teams, Medical and Laboratory Directors, ensure proper information flow and problem resolution.
Assist the Lab Director on identifying areas for process improvement, develop and implement new procedures and contributing to the continuous improvement of laboratory operations.
Ensure projects are completed in a timely fashion.
Oversee new products and services.
Participate in initiatives that increase visibility and grow new business, including conferences, publications, and other types of outreach.
Evaluate new and emerging technologies and makes recommendations bases on these evaluations.
Identify and implement quality indicators and provides regular reports on the status of these indicators.
Provide effective customer service by partnering with internal business units to resolve customer issues.
Work as an individual or on a team for assigned special projects.
Make recommendations for improvement of practices in assigned business units.
Attend professional development seminars, conferences and meetings as required.
Any related duties as assigned.