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.

Position Overview:

In this role, you will have the opportunity to lead a team of dedicated and high-performing scientists to direct the development and qualification of analytical assays for release and characterization testing of our platform technologies of novel biotherapeutics, from live virus products to synthetic peptide vaccines. This team also heavily supports analytics for preclinical animal studies. Current products are in early clinical development and so many assays are at the starting line of their analytical life cycle management. This is an opportunity to establish rigorous and far reaching processes for assay qualification and validation, with an eye to Phase 3 and beyond. This role will necessitate partnering very closely with many other teams within Technical Operations (Bioprocess Engineering, Manufacturing Sciences, Quality Control, Analytical Operations, Quality Assurance), Regulatory Affairs, and Research (preclinical studies) to generate assays that are relevant and cutting edge. The associate director of analytical development will also be involved at times in meetings with external parties in support of regulatory interactions, diligence meetings, business partnerships, etc. This role will have elements of technical oversight, helping the team strategize and investigate technical problems, and operational oversight, ensuring that resources are used wisely and the team is supported in their efforts.

We are looking for a scientist that enjoys working as a team and growing as a leader, someone that believes that WHAT we do and HOW we do it are both critical to success. We are looking for a leader that can prioritize a heavy workload where resources are always limiting, supporting higher level discussions around regulatory implications and employee career development, as well as someone that is willing to roll up their sleeves and pitch in on the ground floor when required. You’ll have experience working with some or all the following, as they relate to analytical development:
• Priority areas of interest:
o Biophysical and analytical chemical methods that support particle measurements, virus particle state assessment, and protein profiling with special attention to HPLC-based methods. Understanding of other related methods such as LC-MS, DLS, zetasizer, nanosight, FFF-MALS, etc are considered an asset.
o In depth knowledge of the methods, instruments, and regulatory considerations of next generation sequencing and it’s use in GMP environments considered an asset
o Experience developing qPCR methods for GMP an asset
• Secondary areas of interest (already well supported within the team, but further asset in understanding critical methods): Cellular and molecular methods such as virus titering by plaque assay, genome quantitation by qPCR, impurity assessment by ELISA or qPCR, etc.
• Developing analytics for biological product characterization and release, experience with live virus products an asset
• Engaging in discussions with colleagues on their analytical needs, assessing/investigating various technologies to support those needs, and making decisions on technologies to pursue
• Supporting Quality Control scientists in their suspect results investigations to ascertain root cause and path forward
• Developing methods to support GMP product characterization or release and supporting the method life cycle management
• Developing methods to support preclinical studies to interrogate virus or protein levels in animal tissues – GLP knowledge an asset
• Performing or managing assay qualification and validation according to principles in ICH Q2, especially as is appropriate to support early clinical development
• Working closely with external CROs and vendors to drive projects to completion in a timely and scientifically sound manner
• Act as subject matter expert in analytical development during diligence and regulatory interactions
• Experience working within GMP quality systems is a must (change control, deviations, corrective and preventive actions, document control)

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:

Qualifications:

This role is best suited for a scientist with 8+ years experience in directly leading analytical method development and qualification of complex biologics in support of GMP clinical product release, leading complex projects, and supporting regulatory submissions. Candidates for this roles will have directly coached and supervised a team of analytical scientists for at least 5 years and worked with external vendors to achieve a project goal. Candidates have likely achieved either a Masters or PhD in a relevant scientific discipline and are looking to use their knowledge in a meaningful and impactful way, while also learning about new methods, products, and processes. Candidates with less formal academic training may also be considered, but having more deep, diverse, and extensive experience will be crucial. Learning agility is critical as the methods leveraged by the Turnstone CMC analytics team are extremely broad and cutting edge. Candidates have demonstrated the ability to manage both small and large projects, multi-tasking effectively, and having an external presence that is professional, collaborative, and influential.

Travel during the COVID-19 pandemic is highly restricted and unlikely to be necessary. However, upon resumption of regular office life, you will need to travel on occasion to our various vendors (global) and also visit our Ottawa and NYC offices often to stay connected, productive, and excited. This role will report to the Director of Analytical Development and Quality Control at Turnstone. Based on a mutual discussion of fit, the successful candidate(s) will reside at either the Ottawa or New York office location, though special consideration will be given to anyone living in eastern North America who is able to travel on occasion (post COVID-19).

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.