Cancer Immunotherapy
Re-Engineered

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.

Position Overview:
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

To Apply:
Please click here to apply!

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.

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.

Position Overview:
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.

The responsibilities for this position span across our multi-virus platform and include:

Our Manufacturing Operations (MFG) team is growing. As part of the Technical Operations organization, the MFG team is responsible for GMP manufacturing of Virus Banks, Drug Substance and Drug Product for our clinical-staged assets. MFG supports technology transfers and collaborates closely with the Process Development & Manufacturing Sciences team to develop and capture process knowledge and ensure overall manufacturing success. As a Senior Engineer (or Manager) of Manufacturing Operations on the MFG team, you will report to the Associate Director, Manufacturing. You will be tasked with leading manufacturing campaigns from end-to-end within our external contract manufacturing organization (CMO) network.

The responsibilities for this position span across our multi-modal platform and include:

– Lead manufacturing campaigns and serve as the primary interface with external CMO partners

– Lead manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation

– Lead ongoing batch monitoring including person-in-plant coverage

– Lead cross functional teams to troubleshoot and resolve issues with ongoing manufacturing runs

– Support manufacturing campaign closeout including the review of executed batch records and shipping/logistics of finished material

– Support process development, engineering runs, and other process scale-up related studies

– Support the identification and selection of new external CMO partners

– Support drafting of regulatory documentation including INDs, CTAs, etc.

– Represent the MFG team at Technical Operations cross-functional program meetings

– Serve as the primary interface with Bioprocess Development & Manufacturing Sciences, Quality Control, Quality Assurance, Supply Chain & Logistics, and/or Program Management on select projects, programs, and cross-functional workflows

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. You would have the opportunity to create something new and ‘WOW!’ all of us and grow right along with the company.

Experience & Qualifications:

This Senior Engineer (or Manager) role will be positioned in our Ottawa, Ontario or New York, NY office

· Willingness to travel up to 30-50% to other Turnstone sites and/or external CMOs throughout North America (USA, Canada) and Europe

· BSc in Chemical Engineering or in other related engineering discipline (biochemical, biological, biomedical, mechanical); MSc in a related scientific discipline also considered

· 5-7 years’ experience in a manufacturing operation, manufacturing sciences and technology, manufacturing technical support, or quality engineering role

· Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics is considered important

· Experience with aseptic manufacturing processes such as the fill/finish of drug product and/or non-terminally sterilized drug substance is considered important

· Experience with good manufacturing practices (GMP) in an early clinical to late phase clinical manufacturing setting is considered important

· Experience managing external relationships such as CMO partners or clients as a CMO provider considered an asset

· Experience with the qualification and operational use of single use, small scale mammalian cell culture, tangential flow filtration, and/or chromatography-based purification equipment and raw materials

· Comfortable leading a cross-functional team in time sensitive, high pressure, and high-risk situations (e.g. manufacturing issue resolution) considered important

· Experience leading a team of direct reports is considered an asset

· Comfortable in a dynamic environment with competing priorities

· Strong technical writing skills

· Strong communication both written, and spoken

· Strong interpersonal skills and a communication style that matches the Turnstone style: respectful, transparent, and constant

· Excellent computer skills, including Microsoft Excel and PowerPoint

To Apply:
Please click here to apply!

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.