Quality Control Technologist

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

Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients. We also expect to initiate two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

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