Supervisor – CCS Quality Control

New York Blood Center Enterprises•Rye, NY

About The Position

The Quality Control Supervisor coordinates and supervises daily product QC and environmental testing activities related to cell therapy manufacturing in a GMP- and GTP-compliant facility. The role primarily oversees analytical and/or microbial testing that supports the manufacture of aseptically processed cell therapy products, and provides technical leadership, daily oversight, and subject matter expertise in GXP-based testing. This position does not perform or supervise CLIA- or NYS CLEP-regulated testing. The supervisor provides analytical and/or microbiological expertise and guidance to ensure appropriate microbial controls and regulatory compliance. The role supports product dispositions, investigations, risk analyses, and mitigations relating to aseptic processing and testing; leads investigations of out-of-specification results, corrective actions, and effectiveness verification; and collaborates on process improvement strategies. The supervisor trains, supervises, and mentors staff, coordinates proficiency testing with the Medical Lab Director, and works with laboratory management to ensure applicable regulatory and accreditation compliance. The position oversees technical transfer, qualification, and validation of QC analytical test methods; supports product stability programs; audits documentation; develops, reviews, and/or approves procedures and related documents; and maintains adequate supply inventory. Additional duties include collaborating with internal and cross-functional teams, participating in continuing education, maintaining training requirements, using laboratory resources appropriately, evaluating technologies and assays, conducting data analysis, preparing reports, and performing other related duties as assigned. The position may require irregular, off-standard, on-call, evening, weekend, or nighttime hours depending on workload and clinical trials, and may require overtime. The supervisor must be able to work in GTP, GMP, and/or cleanroom environments and demonstrate appropriate aseptic technique and cleanroom behavior. For applicants working in New York City or Westchester County, the proposed annual salary is $125,000 to $135,000. Outside those areas, salary reflects local market rates and is commensurate with skills, job-related knowledge, and experience. New York Blood Center (NYBC), founded in 1964, serves the tri-state area and is part of New York Blood Center Enterprises (NYBCe), which operates across more than 17 states. NYBCe delivers blood products and cellular therapies, specialty pharmacy, and medical services. NYBC is an equal opportunity employer.

Requirements

Bachelor's degree or higher in biology, chemistry, clinical laboratory technology, or physical sciences.
With a bachelor's degree, at least four years of pertinent laboratory experience; with a master's degree in a chemical, physical, or biological science, at least two years of pertinent laboratory experience.
Detailed understanding of scientific principles and theories used in quality control of analytical and microbial testing.
Knowledge of GTP, GMP, OSHA (including biosafety), 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.
Experience or knowledge working in a regulated cGMP environment.
Experience or knowledge in equipment qualification, software validation, and analytical method transfer, verification, and validation.
Cultural competency and ability to communicate effectively and sensitively with people from diverse backgrounds.
Excellent verbal and written communication skills.
Proficiency with computer systems and Microsoft Office.
Ability to access, navigate, and work in a GTP, GMP, and/or cleanroom environment.
Ability to plan, organize, and execute protocols under minimal supervision while following cGMP guidelines.
Ability to maintain accurate, detailed documentation according to regulatory guidelines.
Ability to present results periodically and summarize progress to team members.
Ability to work irregular hours, including evenings or weekends, depending on workload.
Ability to work off-standard and on-call hours related to clinical trials, including some nighttime hours during manufacturing; overtime may be required.
Ability to apply good aseptic technique and uphold appropriate cleanroom behavior where applicable.
Ability to become certified in gowning technique for an ISO 7 classified cleanroom and ISO 5 BSC where applicable.
Ability to perform data analysis and trending and generate reports.
Ability to thrive in a fast-paced, creative, and goal-oriented environment and manage multiple projects simultaneously.
Ability to handle confidential information and maintain confidentiality.
Equivalent combinations of education, training, and experience may satisfy the stated requirements.

Responsibilities

Coordinate and supervise daily product QC and environmental testing activities related to cell therapy manufacturing.
Provide technical leadership, daily oversight, and subject matter expertise in GXP-based analytical and/or microbial testing.
Guide staff and operations in implementing appropriate microbial controls to meet regulatory requirements.
Support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and testing.
Lead investigations into out-of-specification test results, corrective actions, and verification of effectiveness.
Collaborate on developing and implementing process improvement strategies.
Train, supervise, and mentor personnel conducting analytical and/or microbial testing.
Coordinate and maintain proficiency testing in conjunction with the Medical Lab Director for relevant QC testing.
Ensure applicable regulatory and accreditation compliance in conjunction with laboratory management.
Oversee technical transfer, qualification, and validation of QC analytical test methods.
Support product stability programs, including protocol generation, testing, and report preparation.
Review and audit documentation for compliance with standard operating procedures.
Develop, review, and/or approve procedures, forms, protocols, and reports supporting manufacturing and testing.
Review and maintain adequate supply inventory.
Establish positive working relationships with internal and cross-functional teams.
Participate in continuing education and complete hours required by governmental agencies and/or accreditation organizations.
Ensure appropriate use of laboratory reagents, equipment, and other resources.
Assist in evaluating new technologies, assays, and clinical research protocols.
Assist with data analysis and report preparation.
Keep individual and staff training requirements up to date.
Perform other related duties as assigned.