Turnstone Biologics Inc. is the leading virus-based immunoncology biotechnology company developing novel oncolytic vaccine therapeutics for cancer patients. Our first-in-class platform technology attacks tumors using a two-pronged approach: targeted and robust tumor killing using an oncolytic virus, in combination with a cancer vaccine that generates long-lasting anti-tumor immune responses. Turnstone is building a world-class, high-performing team 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, Canada and New York, USA. For more information, please visit www.turnstonebio.com or email firstname.lastname@example.org.
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.
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 a
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.