Quality Control Technologist II

Location
Louisville, KY
Posted
Apr 30, 2021
Ref
1024
Discipline
Quality, Quality Control
Required Education
Doctorate/PHD/MD
Position Type
Full time
Job Title: QC Technologist II

Schedule: Full-time

Location: Louisville, KY

Classification: Salaried

Reports to: Quality Control Supervisor

Direct Reports:N/A

Position Summary:

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.

Principal Duties and 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
  • 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 Education, Training, and Experience Required:
  • Bachelor’s degree in related field of Science
  • 3-5 years of relevant laboratory experience
  • 2-3 years of experience with flow cytometry
  • 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


Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift 50 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 biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. 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 2009 – 2016, 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. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we have a corporate office in Boston, MA