Turnstone Biologics is a clinical-stage, immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies for patients with a broad range of solid tumors. Turnstone’s unique, first-in-class oncolytic viral immunotherapies combine the potent tumor-killing effects of an oncolytic virus with a tumor-targeted T-cell vaccine to harness an individual’s own immune system to attack the tumor, preventing recurrence and delivering a cure. Turnstone’s robust pipeline of early-stage compounds, based on its MG1 oncolytic virus platform, are in development for multiple solid tumors and are being evaluated in combination with other cancer immunotherapies, including checkpoint inhibitors, to drive unprecedented, durable T-cell immune responses and strong anti-tumor activity and prevent recurrence. Turnstone is building a world-class, high-performing company that embraces being a learning organization with a sense of urgency. 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, Hamilton, Canada and New York, USA.
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 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.
Our Bioprocess Development and Manufacturing Sciences (PDMS) team is growing. As part of the Technical operations organization, the PDMS team is responsible for leading the overall strategy and technical development for Drug Substance, and Drug Product of our clinical-staged assets. PDMS also supports technical transfers and collaborates closely with Manufacturing to provide technical support for GMP operations. Reporting to the Manager of Downstream Process Development you will be heavily involved in downstream process development activities spanning our viral and non-viral platforms. Responsibilities include:
· Act as subject matter expert for the design of process development studies, data analysis, and interpretation of data
· Act as SME lead for work executing in CDMO partner labs
· Develop & support robust, scaleable purification process by evaluating novel and advanced technologies for our virus portfolio
· Lead efforts to evaluate different resins, filters, and analytical methods pertinent to purification development activities
· Support the training of lab staff on downstream purification equipment
· Participate in technology transfer to our local and international CMO partners
· Support Manufacturing Sciences team with scale-up of the manufacturing processes, and deviation investigations
· Employ QbD principals to perform process characterization studies (e.g. Impurity clearance, process limit evaluations, and identifying operational design space)
· Act as subject matter expert for review of data in regulatory filings
· Draft and review study protocols, test-methods, SOP’s, work instructions and study reports
· Support ongoing batch monitoring (engineering and GMP batches) including person-in-plant coverage
· Share information and harmonize development within the PDMS and TechOps teams as necessary. Ensure good teamwork and support high-quality deliverables
· Perform daily duties to comply with Turnstone’s employment, health & safety, and labour policies, procedures and regulations
· Effectively collaborate with a fully integrated team to facilitate the success of projects
What’s in it for you?
In this role, you will have the opportunity to develop your ability to think both strategically and drive fast-paced execution. With our company size and growth we will give you plenty of opportunities for you to be an inspirational and collaborative co-functional leader. Passionate about being a part of a critical function of a growing company and continuous learning? We will have plenty of that for you!
We are in the early stages of building strategies, structures and process so this role will be busy and expanding. We also have opportunities for you to be a mentor to other team members. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.
The ideal candidate would possess:
· Masters or PhD in Biochemical Engineering, Biotechnology or in other related Science field (virology, biology, biochemistry, protein chemistry, pharmaceutical chemistry)
· 3-4 years of experience in downstream process development, chromatography (affinity, ion Exchange, hydrophobic interaction & mixed-modal chromatography), Filtration (clarification, TFF and sterile filtration)
· Experience working with GE AKTA chromatography systems and Unicorn Software is preferred
· Experience in virus purification is an asset
· Experience with mammalian cell culture in adherent and/or suspension bioreactors is considered an asset
· Able to manage competing priorities effectively and adapt to changing priorities
· Ability to work independently and as part of a team
· Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multi-task
· Excellent communication skills with the proven ability to build open and collaborative relationships, work effectively as a member of a multidisciplinary team
· Excellent computer skills, including JMP, Microsoft Excel, Powerpoint and Word
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.