Quality Control Scientist III

Location
Louisville, KY
Posted
May 30, 2021
Ref
1020
Required Education
Bachelors Degree
Position Type
Full time
Job Title: Quality Control Scientist III

Schedule: Full-time

Location: Louisville, KY

Reports to: Supervisor, Quality Control

Direct Reports: No

Position Summary:

The Quality Control Scientist III is responsible for day-to-day Quality Control (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:
  • Organize the QC laboratory in preparation for testing, ensuring all materials and equipment required for testing are available and ready for use.
  • Perform analytical tests including flow cytometry, endotoxin, sterility and cell counts, potency and other assays related to the quality control of a cell therapy product
  • Perform daily calibration, maintenance and routine cleaning of laboratory equipment
  • 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
  • Act as a subject matter expert (SME) for specialized technical equipment and complex analytical test methods
  • Act as Team Lead for in-process and final QC testing and act as Team Lead for QC release testing. Organizes QC team members, ensuring all roles are covered for testing
  • Review and revise SOPs, prepare protocols and reports for equipment qualifications, analytical test method qualifications and validations
  • Oversee execution of qualification and validation protocols
  • Provide scientific support and oversight for complex analytical methods, interpret data and support scientific research and development activities


Secondary Responsibilities:
  • Lead clinical research and development projects
  • Assist in conducting data analysis and prepare reports
  • Lead training in complex QC analytical procedures and approved SOPs
  • Participate in program organization activities such as equipment maintenance, inventory management, ordering of supplies, and facility monitoring and maintenance
  • Recognize, monitor and evaluate technical, quality, equipment, physical conditions or problems; identify and implement solutions to problems
  • Assist in evaluating new technologies, assays and clinical research protocols
  • Provides QC-related coaching and assists in career development and performance management
  • Perform related duties as assigned


Minimum Education, Training, and Experience Required:
  • M.S. or Ph.D. in Biology, Immunology or related field of science with a minimum of 10 years of relevant laboratory experience
  • Experience in flow cytometry, cell culturing, cell processing, blood banking, or transfusion service preferred
  • Strong understanding of hematology and immunology concepts, and cell therapy
  • Strong understanding of CGMP or GLP/GCP, and GDP


Additional Qualifications
  • Prior knowledge of cell therapy processing of whole blood, apheresis, and other cellular products beneficial
  • Proficiency with technical skills, analytical skills, and solutions-oriented approach to problem-solving
  • General laboratory skills and knowledge of laboratory safety, including universal precautions and sterile/aseptic technique
  • 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 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


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.