Quality Control Technologist

Job Title: Quality Control Technologist
Schedule: Full-time
Location: Louisville, KY

Job Description
This position is responsible for day-to-day Quality Control and Analytics related to the conduct of Clinical Phase I, II, and III trials in cell therapy. This includes performing analytical testing under Good Manufacturing Practices (GMP) 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 programmatic organization activities.
Primary Responsibilities:
  • Perform analytic tests including flow cytometry, endotoxin, sterility and cell counts, CFC and other assays related to the quality control of a cell therapy product in accordance with Batch Production Records and approved Standard Operating Procedures (SOPs) and adhering to the applicable regulations and standards, including Good Manufacturing Practices (GMP), Good Tissue Practice (GTP), and American Association of Blood Banks (AABB) standards
Secondary Responsibilities:
  • Participate in clinical research and development
  • Conduct data analysis and prepare reports, working under general supervision
  • Participate in programmatic organization activities such as equipment maintenance, inventory management, ordering of supplies, preparation of SOPs and facility monitoring and maintenance
  • Participate in training professionals or graduate students in laboratory procedures and approved SOPs
  • Perform related duties as assigned
Minimum Requirements
  • Bachelor’s degree in related field of Science + 2 years of relevant laboratory experience
  • Experience in cell culturing, cell processing, blood banking, or transfusion service preferred
  • General understanding of hematology and immunology concepts
  • Please note: an equivalent combination of education, training, and/ or professional experience may be considered in substitute for requirements listed
Additional Qualifications
  • General understanding of the field of cell therapy processing and cryopreservation preferred
  • Prior knowledge of cell therapy processing of whole blood, apheresis, and other cellular products preferred
  • Proficiency with technical skills, analytical skills, and solutions-oriented approach to problem-solving
  • General laboratory skills and knowledge of lab safety, including universal precautions, sterile technique and radioisotope safety
  • Experience in Flow Cytometry, Blood Cell Counting preferred
  • Experience in following standard operational protocols for complex or advanced assays preferred
  • Ability to work effectively in a fast-paced, rapidly changing environment
  • Flexibility and dedication: Position will require “off-standard hours” and “on-call” hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime
Apply: Please submit resume or CV and cover letter to careers@talaristx.com