Job Title: Cell Processing Associate I, Manufacturing Operations
Schedule: Full-time (1st/2nd Shift)
Location: Louisville, KY
Reports to: Senior Supervisor, Manufacturing Operations
Direct Reports: N/A
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
A Cell Processing Associate I, to be based in Louisville, KY is a production professional responsible for the day-to-day operations related to clinical cell therapy manufacturing in a GMP and GTP compliant ISO 7 classified cleanroom facility. The primary responsibilities of this role focus on cell processing; secondary responsibilities include development and programmatic organization activities.
Principal Duties and Responsibilities:
- Demonstrates strong aseptic technique
- Adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
- Ability to gown to work in a cleanroom environment (ISO 8, 7, 5)
- Demonstrates proficiency in Good Documentation Practices
- Use of manufacturing and cryopreservation equipment, including routine cleaning and maintenance
- Participate in clinical research and development
- Assist in the development and revision of SOPs
- Participate in programmatic organization activities such as equipment maintenance, inventory management, ordering of supplies, preparation of SOPs and facility monitoring and maintenance
- Responsible for maintaining training requirements up to date
- Perform related duties as assigned
Minimum Education, Training, and Experience Required:
- Bachelor’s degree in related field of Science or equivalent combination of education, training, and experience
- 6 months general laboratory experience
- Experience in cell culturing, cell processing, blood banking, or transfusion service preferred
- General understanding of hematology and immunology concepts
- Good Manufacturing Practices (GMP), Good Tissue Practice (GTP), and American Association of Blood Banks (AABB) standards
- Please note: an equivalent combination of education, training, and/ or professional experience may be considered in substitute for requirements listed
- General understanding of the field of cell therapy processing and cryopreservation preferred
- Knowledge of technical skills, analytical skills, and solutions-oriented approach to problem-solving
- General lab skills and knowledge of lab safety, including universal precautions, and sterile technique
- Ability to work effectively in a fast-paced, rapidly changing environment
- Flexibility and dedication: Position will require “off-standard hours” and “on-call” hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime
- Please note that the position requires a general occupational health screening performed by an approved occupational health unit to work with the “open product” in the bone marrow processing cGMP facility.
- Applicants who intend to work with open product shall not submit to a health screen until after an offer of employment has been made.
- 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 cleanroom environment.
- Ability to work some irregular hours, including evenings or weekends, depending on workload
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off 25 days
- Stock Options
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.