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Cell Processing Technologist

Company: Talaris Therapeutics
Location: Louisville
Posted on: February 15, 2020

Job Description:

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 Title: Cell Processing Technologist Schedule: Full-time Location: Louisville, KY Job Description This position is responsible for day-to-day operations related to the conduct of Clinical Phase I, II, and III trials in cell therapy. This includes Good Manufacturing Practices (GMP) production of a cell therapy product and research and development. The primary responsibilities of this role focus on cell processing; secondary responsibilities include clinical research and development and programmatic organization activities. Responsibilities include:

  • Conduct aseptic cell processing to produce preclinical and clinical lots of the FCR001 product, following established Standard Operating Procedures (SOPs) and batch records and adhering to applicable regulations and standards
  • Proficiently function within an ISO Class 7 and 8 clean room environment, ensuring personal safety and product safety
  • Maintain consistent and accurate documentation, following Good Documentation Practices
  • Perform cryopreservation of the cell therapy product using a controlled-rate freezer
  • Proficiently operate and maintain equipment according to designed procedures. Equipment may include use of CliniMACs cell separator, controlled-rate freezers, temperature monitoring systems, alarm systems, biological safety cabinets, liquid nitrogen freezers, micropipets, refrigerators, ultra-cold freezers, tube sealers, dry shippers, and centrifuges
  • Notify Management of any deviation that may occur during processing and complete all related documentation in a timely manner
  • Participate in R&D and research related to production of the cell therapy product. Responsibilities may include sample preparation, sample shipping, and preparation of media or reagents
  • Perform related duties as assigned Minimum Requirements
    • Associate's Degree in a related field of Science + 2 years relevant work experience
    • Current Medical Technologist license or equivalent professional certification preferred
    • Experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing facility preferred
    • Ability to work effectively in a fast-paced environment and consistently meet deadlines
    • Strong work ethic, methodical approach to new challenges
    • Team-oriented interpersonal skills are essential
    • Flexibility and dedication: Position will require "off-standard hours" and "on-call" hours related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime.
    • Please note that the position requires a general occupational health screening performed by an approved occupational health unit to work with the cell therapy product in the cGMP cleanroom facility. These examinations are necessary to protect the cell therapy product during the manufacturing process. Applicants who intend to work with the open product shall not submit to a health screen until after an offer of employment has been made. Apply: Please submit resume or CV and cover letter to

Keywords: Talaris Therapeutics, Louisville , Cell Processing Technologist, Other , Louisville, Kentucky

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