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.

The Quality Control Supervisor is responsible for coordinating and supervising the daily activities related to clinical cell therapy manufacturing in a GMP and GTP compliant facility. The primary responsibilities of this role are focused on the analytical and/or microbial testing in place to support the manufacturing of aseptically processed cell therapy products. Secondary responsibilities of this role will include providing technical leadership, daily oversight, and subject matter expertise in GXP and CLIA based testing.

• Provides the analytical and/or microbiological expertise, leadership, and guidance to ensure operations and staff implement appropriate microbial controls to meet regulatory requirements.
• Provides expertise to support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and testing.
• Leads investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Leads collaboration to develop and implement process improvement strategies.
• Train, supervise, and mentor personnel to develop a strong team of highly skilled professionals responsible for conducting analytical and/or microbial testing.
• Coordinate and maintain proficiency testing in conjunction with the Medical Lab Director for relevant QC testing.
• Ensures regulatory and accreditation compliance in conjunction with the lab management including FDA, NYSDOH, AABB, and FACT as applicable.
• Oversee the technical transfer, qualification, and validation of QC Analytical test methods.
• Support product stability programs including generation of stability protocols, execution of stability testing, and generation of stability reports.
• Reviews/audits documentation to ensure processes are performed and documented as directed by standard operating procedures.
• Develops, reviews, and/or approves procedures, forms, protocols, and reports in support of manufacturing and testing activities.
• Reviews and maintains an adequate supply inventory.
• Establish positive working relationships with internal and cross-functional teams.
• Participate in Continuing Education activities. Completes hours required by governmental agencies and/or accreditation organizations.
• Responsible for appropriate use of laboratory reagents, laboratory equipment and other resources.
• Assist in evaluating new technologies, assays, and clinical research protocols.
• Assist in conducting data analysis and preparing reports.
• Responsible for keeping individual and staff training requirements up to date.
• Any related duties as assigned.

Education:

• Bachelor’s or higher degree in clinical laboratory technology, or
• Bachelor's or higher degree from a program with a major in biology, chemistry, or the physical sciences, and: current license or certification as a clinical laboratory technologist, or completion of an accredited clinical laboratory technology program, or two years of experience working as a licensed clinical laboratory technician.
• Master’s degree with 3 years of cGMP and/or CLIA/CLEP experience.
• Education and training sufficient to qualify for licensure as a Clinical Laboratory Technologist prior to 2009 as specified in NYS-ED Regulation 79-13.4.

Experience:

• If bachelor’s degree, at least four years of pertinent clinical laboratory experience subsequent to qualifying as a clinical laboratory technologist.
• If master’s degree with a major in one of the chemical, physical or biological sciences, qualifies as a clinical laboratory technologist, and subsequent to graduation, has at least two years of pertinent clinical laboratory experience.
• 5 years of experience in biopharmaceutical and/or clinical laboratories preferably in a clinical trial or FDA-approved products setting.
• 1 year of lead or supervisory experience with knowledge of hematopoietic stem/progenitors, aseptic techniques, hematology, flow cytometry, PCR, and/or microbiological testing.

Licenses / Certification:

• Current active NY State License as a Clinical Lab Technologist, or current active NY State issued Restricted License in Cellular Therapy.
• Must meet the minimum requirements to qualify as a General and/or technical supervisor per CLIA/CLEP regulations.

Knowledge:

• Demonstrate detailed understanding of applicable scientific principles and theories used in the quality control of analytical and microbial testing.
• Knowledge of GTP, GMP, OSHA (including biosafety), CLIA, FACT, and FDA regulations.
• Knowledge of hematology analysis, flow cytometry, PCR, potency assays, endotoxin, colony forming unit assays, microscopy, gram stain, sterility, and environmental monitoring.
• Experienced or knowledgeable in working in a regulated cGMP environment.
• Experienced or knowledgeable equipment qualification, software validation, and analytical method transfer/verification/validation.

Skills:

• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• Excellent verbal and written communication skills.
• Proficiency in computer systems and Microsoft Office suite.
• Must be able to access, navigate and work in a GTP, GMP, and/or CLIA/CLEP laboratory and/or cleanroom environment.
• Plan, organize and execute protocols under minimal supervision following cGMP guidelines.
• Maintain accurate and detailed documentation according to regulatory guidelines.
• Periodically present results and summarize progress to team members.

Abilities:

• Ability to work some irregular hours, including evenings or weekends, depending on workload.
• Ability to work “off-standard hours” and “on-call” hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime.
• Demonstrate the ability to apply good aseptic technique and uphold appropriate cleanroom behavior where applicable.
• Demonstrate the ability to be certified in gowning technique for ISO 7 classified cleanroom and ISO 5 BSC where applicable.
• Ability to perform data analysis, trending, and generate reports as required.
• Ability to strive in a fast-paced, creative, and goal-oriented environment.
• Demonstrate ability to manage multiple projects simultaneously.
• Ability to handle 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 $142,142.00p/yr. to $154,422.00p/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.