Turnstone Biologics’ mission is to deliver breakthrough immunotherapies to improve survival for people with cancer. Our first-in-class platform technology is a disruptive class of engineered viral immunotherapies, attacking cancer’s complexity with medicines designed to fight tumors at multiple points of intervention, including simultaneous generation of targeted immune responses and modulation of the tumor environment. Turnstone is building a world-class, high-performing CMC team that embraces being a learning organization with a sense of urgency, where CMC is a differentiator and enabler rather than a cost-center. Turnstone has a seasoned board of directors and venture capital partners, is enrolling clinical studies, has a rich development portfolio, and highly active R&D efforts led by a world-class scientific management team. Turnstone is co-located in Ottawa, Canada and New York, USA.
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 Thursday at Turnstone’? At Turnstone, the science drives decision making, and our drugs 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.
This position is a 6 month contract with the opportunity for renewal, pending the assessment of project outcomes, resource allocations, and mutual assessment of it.
• Perform technical review of analytical data for completeness, accuracy, and GxP compliance in a timely manner to support critical timelines for delivering investigational drug to clinical trials
• Support the execution of new launches, processes and procedures, perform multi-batch trend analysis and compile study documentation
• Work with Quality Control colleagues, vendors, and cross functional teams to support investigations and projects
• Perform Raw material review and assessment for compliance with compendial requirements and specifications.
• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings, and internal communication avenues
• Supports designing and implementation of Quality control projects to comply with GxP, regulatory, and Turnstone policies.
• Support management of inventory for QC reference standards, cell banks, and GxP material
This role is best suited for an analyst with the following:
• 2+ years of hands-on experience in the lab performing and data review of methods such as:
o virological and cellular assays (tissue culture, plaque assay, etc)
o molecular assays (qPCR, PCR, ELISAs, Western blot, etc)
o Compendial methods (Sterility, Endotoxin, Mycoplasma, adventitious agents etc)
• Education: diploma or degree in microbiology, biochemistry, biotechnology, or relevant field
• 2+ years experience in Quality control performing product release testing and review
• Knowledge in biological drugs such a viral vaccines, gene therapy, and cell therapies an asset
• Experience using Microsoft applications (Excel, Word, PowerPoint)
• Experience with analytical software such as JMP would be an asset
• Must have knowledge of GMP regulations
• Good organizational and time management skills
• Demonstrated attention to details
• Excellent communication and able to work with different teams
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.