Technologist, Quality Control

Location
Louisville, KY, United States
Posted
Jan 30, 2021
Ref
1795733583
Discipline
Quality, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time
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.

Job Title: Technologist, Quality Control
Schedule: Full-time
Location: Louisville, KY
Reports to: Manger, Quality Control
Direct Reports: No

Position Summary:

The Quality Control (QC) Technologist position reports to the QC Manager and is responsible for day-to-day QC and analytical testing related to the conduct of Phase I, II, and III clinical trials for a novel cell therapy. This includes performing analytical testing under current Good Manufacturing Practices (cGMP) 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 program 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

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:
  • 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
  • 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 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 GMP 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

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is fully committed to equality of opportunity in all aspects of employment. It is the policy of Talaris to provide equal employment opportunity to all employees and applicants without regard to race, color, religion, national or ethnic origin, military status, veteran status, age, gender, gender identity or expression, sexual orientation, genetic information, physical or mental disability or any other protected status.