At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

The Quality Control Analyst III is responsible for day-to-day Quality Control (QC) and analytical testing related to the conduct of Phase I, II, and III clinical trials for cell and gene therapies. This includes performing analytical testing under Current Good Manufacturing Practices (CGMP) production of a cell therapy product, immunologic monitoring of test samples, research, and development. The primary responsibilities of this role focus on manufacturing; secondary responsibilities may include clinical research and development and program organization activities.

Location: Louisville, KY

Organize the QC laboratory in preparation for testing, ensuring all materials and equipment required for testing are available and ready for use.
• Perform analytical tests including flow cytometry, endotoxin, sterility, and cell counts, potency and other assays related to the quality control of a cell therapy product.
• Perform daily calibration, maintenance, and routine cleaning of laboratory equipment.
• Perform work in accordance with Batch Production Records and approved Standard Operating Procedures (SOPs).
• Adherence to the applicable regulations and standards, including CGMP, Good Documentation Practices (GDP), Good Tissue Practices (GTP), and American Association of Blood Banks (AABB) standards.
• Act as a subject matter expert (SME) for general equipment and/or basic analytical test methods.
• Prepare and revise SOPs and, with guidance, prepare protocols and reports for equipment qualifications, analytical test method qualifications and validations.
• Flexibility and dedication: Availability to participate outside of, and in addition to, normal work hours as required, including some nighttime hours during clinical processing and some weekend coverage.
• Participate in clinical research and development.
• Conduct data analysis and prepare reports, working under general supervision.
• May participate in training in QC analytical procedures and approved SOPs.
• Participate in program organization activities such as equipment maintenance, inventory management, ordering of supplies, and facility monitoring and maintenance.
• Recognize, monitor and evaluate technical, quality, equipment, physical conditions or problems.
• Perform related duties as assigned.

Education:

• B.S. or M.S. in Biology, Immunology, or closely related field of science.

Experience:

• Minimum of 5 years of relevant laboratory experience.
• Experience in flow cytometry, cell culturing, cell processing, blood banking, or transfusion service(preferred).

Knowledge:

• Good understanding of hematology and immunology concepts
• Understanding of CGMP or GLP/GCP, and GDP
• Prior knowledge of cell therapy processing of whole blood, apheresis, and other cellular products beneficial
• Proficiency with technical skills, analytical skills, and solutions-oriented approach to problem-solving.
• General laboratory skills and knowledge of laboratory safety, including universal precautions and sterile/aseptic technique.
• Must be able to access, navigate and work in a CGMP laboratory environment.

Skills & Abilities:

• Ability to work effectively in a fast-paced, rapidly changing environment.
• Demonstrated critical thinking and troubleshooting skills.
• Attention to detail in all work processes.
• Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings.

For applicants who will perform this position in New York City or Westchester County, the proposed hiring rate $41.03p/hr. 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.