Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ. 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 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression. We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years. Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients. Talaris recently closed a $100M private financing from leading life sciences investors. We will be initiating a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients later in 2019. We will also be initiating two Phase 2 trials of our therapy in additional indications in 2020. Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.
The GMP Facility Manager will be responsible for the overall management of our GMP manufacturing facility. This role will report to the Senior Vice President of Technical Operations.
The GMP Facility Manager ensures the facility utilized in cell processing remain continuously compliant with regulatory requirements and best practices. This position coordinates all aspects of the facility maintenance management program to ensure reliable and compliant operation. The facility consists of ISO 7 and ISO 8 cleanrooms utilized to perform pharmaceutical manufacturing activities, Quality Control laboratories, research laboratories, and controlled inventory space.
- Manage facility maintenance activities using the CX Alloy FM CMMS software system
- Work closely with Talaris Quality Assurance department on all facility and equipment related issues
- Act as a liaison between Talaris and the University of Louisville physical plant maintenance department to coordinate base building activities required to maintain GMP compliance; schedule facility preventive maintenance and repair activities as needed.
- Manage and supervise Talaris facility personnel
- Review and approve all documentation generated during facility inspections and audits
- Manage document archive system for facility and equipment related documents
- Manage and provide coordination for all contracted service vendors utilized to perform certification, maintenance and repair activities
- Manage the maintenance, repair, validation, calibration and certification of all equipment utilized in the manufacturing and Quality Control processes
- Manage schedule and provide oversight to personnel and/or contractors who will perform cleaning of GMP cleanrooms per SOP
- Administer the qualified environmental monitoring system (Lighthouse)
- Act as alarm response contact for the environmental monitoring program and for facility alarms generated by campus maintenance department
- Provide training on established procedures to staff, campus maintenance department personnel, and contracted vendors as required to perform work in a regulated manufacturing environment
- Act as the Subject Matter Expert (SME) for all facility and equipment related processes
- Develop additional Standard Operating Procedures (SOPs) for facility and equipment related processes as needed
- Build, inspire and appropriately align and integrate personnel to achieve business results
- Perform additional job-related duties as required
- Bachelor’s degree in engineering or related field plus 5+ years facility infrastructure and operations management for GMP production in pharma, biotech, or cell and gene therapy industry; or equivalent combination of education and experience
- Thorough understanding of the operation of facility systems including HVAC, electrical, plumbing
- Thorough understanding of GMP requirements related to facility management
- Demonstrated ability to work effectively in individual settings and in cross functional teams
- Strong interpersonal verbal and written communication skills
- Familiarity with common GMP manufacturing equipment a plus
- Self-directed and able to manage competing priorities