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 has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients. We also expect to initiate 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 Quality Assurance Specialist is responsible for assisting in the development and maintenance of Quality Management Systems to support the clinical manufacturing program at Talaris. The Talaris manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled cleanroom facility designed to enable production of regenerative medicine products.
The QA Specialist will be responsible for quality systems including maintenance of document control (scanning and archiving of GMP documentation) and monitoring and maintenance of records (cGMP guidelines, training, pertinent regulations, vendor qualifications, policies and standard operating procedures). The QA Specialist will independently prepare, perform and maintain internal audit/review systems (manufacturing batch records, RedCap database, deviations, quality control analysis and result reports and change controls). This position will require independent authoring of internal regulatory (audit/review) reports for senior leadership review and approval.
Additional duties will include authoring/finalizing protocols provided by third parties, assisting with the development of new labelling systems, and serving as a liaison with laboratory staff. This position requires a high level of autonomy and will be required to search information, independently prepare reports and provide recommendations for the QA unit, interact with a number of outside vendors to obtain regulatory documentation/coordinating the testing of research materials and conducting audits.
The Quality Assurance Specialist will report to the Quality Assurance Manager..
- Maintain Quality Assurance unit document control and records, including:
– Manufacturing process validations and studies– Faculty and staff training records– Environmental maintenance and Iso7 GMP facility records– Audit and review documentation– Vendor qualification documentation, including certification paperwork– Policies and Standard Operating Procedures (SOPs)– External party training records
- Interact with a number of outside vendors to obtain regulatory documentation and vendor qualification information, coordinate identity testing of research materials, and plan external audits
- Independently prepare, perform and maintain internal audits and reviews requiring a high degree of autonomy; independently author internal regulatory (audit/review) reports for senior leadership review and approval
– Review Manufacturing batch records for adherence to Good Documentation Practices (GDP) and verification of all calculations for accuracy– Independently review deviations and change controls for QA Management review and approval– Aid in review of Quality Control analysis and results– Monitor / audit web-based clinical trial database (RedCap)
- Prepare Documentation, Protocols and Standard Operating Procedures (SOPs). Research information, independently prepare reports and provide recommendations for the QA unit.
– Author, revise and track Standard Operating Procedures– Assist in authoring and/or finalizing protocols provided by third parties– Prepare documentation regarding vendor qualification requirements; independently contact vendors and review vendor – qualifications
- Develop regulatory tracking documentation and work with unit senior leadership to ensure timelines achieved
- Act as Quality Assurance liaison with the analytical and manufacturing researchers
- Assist with the development of a new labelling system and issuing labels
- Assist team members with other documentation efforts as necessary
- Perform additional job related duties as required
- BS in related field of Science
- 2+ years of experience in a Quality Assurance role; prior experience within a cGTP/cGMP regulated biotech, cell processing (i.e. stem cell or bone marrow processing), tissue bank or pharmaceutical company preferred
- Demonstrated ability to manage and prioritize multiple projects and meet deadlines
- Excellent time management and organizational skills
- Strong written and verbal communication skills
- Experience interacting with regulatory bodies a plus
- Understanding of the field of cell therapy processing and cryopreservation preferred
- Exceptional analytical skills and solutions-oriented approach to problem-solving
- Ability to work effectively in a fast-paced, rapidly changing environment
- Demonstrated ability to work independently as well as part of an integrated team
- Good teaching skills and ability to train others preferred
- Flexibility and dedication: Position may require some “off-standard hours” and “on-call” hours to support specific clinical trials, including some nighttime hours to receive product for manufacturing