Environmental Control Technologist
Job Title: Environmental Control Technologist
Location: Louisville, KY
Reports to: Environmental Control Supervisor
An Environmental Control Technologist is responsible for performing Environmental Monitoring sampling and personnel monitoring to maintain the Environmental Control strategy related to clinical cell therapy manufacturing in a GMP and GTP compliant ISO 7 classified cleanroom facility and ISO 5 biological safety cabinet (BSC).
Principal Duties and Responsibilities:
- Perform Environmental Monitoring (EM) and Personnel monitoring (PM) through obtaining personnel sampling, environmental sampling, and particle sampling.
- Demonstrates the ability to apply good aseptic technique and uphold appropriate cleanroom behavior.
- Demonstrates the ability to be certified in gowning technique for ISO 7classified cleanroom and ISO 5 BSC.
- Responsible for logistics and communication for EM/PM samples shipped to outside contracted vendor.
- Enter, track, and assist in trending EM reports.
- Assist in reviewing EM/PM reports from performing laboratory.
- Assist in developing and authoring new reports and protocols related to EM/PM.
- Assist in creating and presenting quarterly EM data summaries.
- Assist in development and revision of SOPs.
- Assist in examining new equipment, technologies, and/or supplies.
- Must maintain all required training.
- Perform related duties as assigned.
Minimum Education, Training, and Experience Required:
- A Bachelor’s degree in the science field, preferably in microbiology, chemistry, biology, or other related degree.
- Minimum of 2 years’ experience in biopharmaceutical and/or clinical microbiology laboratories, preferably in a commercial or FDA approved products setting.
- Experience preferred with Good Manufacturing practices, Good Laboratory Practices, and good documentation practices. Knowledge of OSHA and FDA regulations.
- Experience with microbiology techniques
- Experience in computer systems and Microsoft Office suite.
- Attention to detail and ability to maintain accurate and detailed documentation according to regulatory guidelines.
- Flexibility to assist in other tasks as needed or assigned.
- 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.
- 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, navigate, and work in ISO 7 classified cleanroom with sterile gowning.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off 25 days
- Stock Options
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.