Quality Control Technician I

Location
Louisville, KY
Posted
Jul 14, 2021
Ref
1031
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Job Title: Quality Control Technician I/II

Schedule: Full-time

Location: Louisville, KY

Reports to: Supervisor, Quality Control

Direct Reports:N/A

Position Summary:

The Quality Control Technician I/II is an entry-level position responsible for day-to-day support of the Quality Control (QC) laboratory and analytical testing related to the conduct of Phase I, II, and III clinical trials for a novel cell therapy. This includes calibration and maintenance of equipment, ordering and stocking of laboratory supplies and performing analytical testing under Current Good Manufacturing Practices (CGMP) for production of a cell therapy product, immunologic monitoring of test samples, research and development. The primary responsibilities of this role focus on laboratory maintenance and manufacturing; secondary responsibilities may include clinical research and development and program organization activities.

Principal Duties and Responsibilities:
  • Perform daily calibration, maintenance and routine cleaning of laboratory equipment
  • Maintain laboratory inventory of supplies
  • Perform analytical tests including flow cytometry, endotoxin, sterility and cell counts, and other assays related to the quality control of a cell therapy product
  • 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


Secondary Responsibilities:
  • Participate in clinical research and development
  • Perform related duties as assigned


Minimum Education, Training, and Experience Required:
  • B.S. in Biology, Immunology or related field of science with less than 1 year of relevant laboratory experience
  • Some experience in flow cytometry, cell culturing, cell processing, blood banking, or transfusion service preferred
  • General basic laboratory skills


Additional Qualifications
  • Ability to work effectively in a fast-paced, rapidly changing environment
  • 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 period of standing, sitting and working on a computer
  • Must be able to lift 50 pounds at times
  • Must be able to access, navigate and work in a CGMP laboratory environment
  • Ability to work some irregular hours, including evenings or weekends, depending on workload


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.