A doctorate degree in Biology or an equivalent field of science, or an MD.
Seven years of experience in a clinical laboratory setting, including experience in a hematopoietic laboratory, a flow cytometry laboratory, or equivalent.
Meet New York State Department of Health requirements for Stem Cell Laboratory Director.
Expert knowledge of practices and procedures in cellular therapy, flow cytometry, and processing.
Knowledge of Microsoft Office Suite and a Manufacturing Execution System or Laboratory Information Management System.
Cultural competency and the ability to communicate effectively in a culturally sensitive manner with individuals and groups from diverse backgrounds.
Strong attention to detail in research and work processes.
Ability to conduct research on various topics and work independently with minimal supervision.
Ability to communicate clearly and authoritatively in writing and verbally, including in one-on-one and small-group settings.
Ability to interact helpfully, courteously, and respectfully with people at all organizational levels and customers, including diverse populations.
Ability to plan and organize tasks or resources efficiently, respond to management, and address issues as they arise.
Ability to work in a fast-paced environment while managing multiple competing tasks and demands.
Ability to use logic and reasoning to analyze alternative solutions and approaches within established policies and procedures.
Ability to identify complex problems, assess information, develop and evaluate options, and implement solutions.
Ability to handle sensitive and confidential information while maintaining confidentiality.
Any combination of education, training, and experience equivalent to the stated requirements that supplies the knowledge, skills, and experience needed to perform the essential functions.
Responsibilities
Oversee daily cellular therapy laboratory operations, including processing, cryopreservation, storage, and distribution of cellular therapy products, ensuring quality, compliance, and efficacy.
Work with the Cell Therapies Lab Director to create standard operating procedures; manage projects and resources, including personnel; oversee project budgets and fee schedules; perform experimental work; develop and implement experimental protocols and workflows; and supervise staff.
Work with leaders of corresponding cGMP and other CCS laboratory teams, clinical apheresis services, business development, and other groups as needed.
Track project timelines and trending data; participate in client meetings, off-site activities and events, and meetings; and help foster client relationships while monitoring trends in clients and service portfolios.
Supervise day-to-day laboratory technical activities, workflows, and resources, including personnel, equipment, and supplies.
Implement and maintain quality control and quality assurance systems, validate new procedures, and ensure compliance with FACT, CLIA, FDA, and other applicable regulatory standards.
Manage, train, and supervise laboratory personnel, including conducting performance evaluations and competency assessments.
Ensure compliance with regulations concerning safety, patient confidentiality, and product handling.
Oversee supplies and reagent inventory, equipment maintenance and calibration, and 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 with clinical teams and Medical and Laboratory Directors to support information flow and problem resolution.
Assist the Lab Director in identifying process improvements, developing and implementing procedures, and continuously improving laboratory operations.
Ensure projects are completed on time and oversee new products and services.
Participate in initiatives to increase visibility and grow new business, including conferences, publications, and other outreach.
Evaluate emerging technologies and make recommendations based on those evaluations.
Identify and implement quality indicators and provide regular status reports.
Partner with internal business units to resolve customer issues and provide customer service.
Work independently or with a team on assigned special projects and recommend improvements to practices in assigned business units.
Attend professional development seminars, conferences, and meetings as required, and perform related assigned duties.
Desired Qualifications
Certificate of Qualification for Flow Cytometry.
New York State Laboratory Technologist License.
Responsibilities
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.
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.
Qualifications
Education:
Doctorate degree in Biology or equivalent field of science, or MD.
Experience:
Seven years’ experience in a clinical laboratory setting which should include experience in a hematopoietic laboratory or a flow cytometry laboratory or equivalent.
Licenses/Certification:
Meet NYSDOH requirements for Stem Cell Laboratory Director https://www.wadsworth.org/regulatory/clep/certificate-requirements
Certificate of Qualification for Flow Cytometry preferred
New York State Lab Technologist License preferred.
Expert knowledge in practices and procedures in cellular therapy, flow cytometry, processing.
Knowledge of various computer software applications (MS Office Suite), MES or LIMS.
Skills:
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.
Abilities:
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.
For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $160,000.00p/yr. to $170,000.00p/yr. 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.
Overview
Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.