Quality Control Technologist II

Location
Louisville, KY
Posted
Jul 21, 2021
Ref
1042
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Job Title: Quality Control Technologist II

Schedule: Full-time

Location: Louisville, KY

Reports to: Supervisor, Quality Control

Direct Reports:N/A

Position Summary:

Reporting to the Supervisor, Quality Control, the Quality Control Technologist II is responsible for the 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.

Principal Duties and Responsibilities:
  • Perform daily QC laboratory analytical tests including flow cytometry, endotoxin, sterility and cell counts, colony-forming unit and other assays related to the potency and quality control of a cell therapy product in accordance with approved Standard Operating Procedures (SOPs)
  • Ensure adherence to the applicable regulations and guidelines, including cGMP, Good Tissue Practice (GTP), and American Association of Blood Banks (AABB) standards
  • Support the qualification and validation of QC equipment and analytical test methods
  • Performs other duties as assigned.


Secondary Responsibilities:
  • Support clinical research and development, with a focus on flow cytometric assays
  • Interpret data analysis and prepare reports
  • Review activities such as equipment maintenance, inventory management, ordering of supplies, preparation of SOPs and facility monitoring and maintenance
  • Participate in training professionals in complex laboratory procedures and approved SOPs
  • Recognize, monitor and evaluate technical, instrumental or physical conditions or problems, identify and implement solutions.


Minimum Education, Training, and Experience Required:
  • B.S., M.S. degree or Ph.D. in Biology, Immunology or a related field, with a minimum of 3 years of relevant laboratory experience


  • Experience in flow cytometry, clinical diagnostics, cell culturing, cell processing, blood banking, or transfusion service required
  • Strong understanding of hematology and immunology concepts, and GMP or GLP/GCP, and GDP


Additional Qualifications
  • Strong understanding of the field of cell therapy processing and cryopreservation preferred
  • 2-3 years working with flow cytometry preferred
  • Prior knowledge of GMP regulations
  • Experience in creating and implementing standard operating procedures for complex, advanced assays required
  • Ability to work effectively in a fast-paced, rapidly changing environment with 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


Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift 15 pounds at times.
  • Must be able to access and navigate each department at the organization’s facilities.


Benefits:
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k

Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ. We have followed these patients for an average of over six years since their transplant, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. We are currently enrolling patients in FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, and in the second half of 2021 we will be initiating FREEDOM-2, in which we will evaluate the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, as well as FREEDOM-3 in which we will evaluate the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 100 employees and have a corporate office in Boston, MA in addition to our cell processing facility in Louisville, KY.