Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
How do you know if you’re the right fit?
Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding are what we call ‘another day at Turnstone’? At Turnstone, the science drives decision making, and our therapies are designed with the patient in mind. Like the disease we’re fighting, our platform is complex, and transformative. If you’re a passionate person, and our science excites you – this opportunity may be for you.
If you are interested in being a part of a growing Regulatory Affairs and Quality Assurance team, then this role may be for you! As the Technical Coordinator, Quality Assurance, Reporting to the Head of Quality you will support the team to establish and implement the quality systems which enable GXP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. The focus will be on GMP activities, with strong interfaces to the technical operations team, the clinical operations team (GCP) and the pre-clinical/R&D team (GLP).
The responsibilities and critical expectations include the following:
• Work within the electronic document management system to support the development of GXP templates, review and approval of SOPs, Forms, Specifications, Master Production Records, Protocols and Reports and other related GMP records
• Coordinate Administration and provide User/Training Support for electronic Quality Management Systems (QMS)
• Assist in development and maintenance of GXP policies and procedures and support the monitoring of its performance
• Support the management of activities related to archival of GXP documents and samples, including scanning where applicable, cataloging, filing, and coordinate shipment of records to and from offsite storage facilities
• Support the management of department/employee training programs and plans
• Coordinate a centralized system for issuance and tracking of GMP document numbers, batch lot numbers, deviation and change control numbers
• Support the management and status tracking of Quality Agreements and Audits including schedules, reports and CAPAs
• Support the design and implement databases as required by Quality Assurance team members
• Support the coordination of QA driven communication, presentations and workshops
• Prepare reports for management review
What’s in it for you?
In this role, you will have the opportunity to develop your ability to build processes and drive these to implementation. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
The Details
This role is best suited for someone with the following:
• College Diploma required, Bachelors degree in Science preferred
• Minimum of 2+ years of experience in QA or in a related field
• Knowledge of documentation control requirements to meet FDA/Health Canada regulations
• Fundamental training in GMP (preferred)
• Experience with Microsoft Computer Products (Word, Excel, Access, PowerPoint). Experience with Document management or QMS etools (Veeva, TrackWise, ShareFile,Egnyte or equivalent)
• Demonstrated ability to manage multiple projects and variable workloads with demanding timelines.
• Strong interpersonal, teamwork, and organizational skills; effective oral and written communication skills.
• The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.