Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021.
At Turnstone, the science drives decision making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. 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 thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.
How do you know if you’re the right fit?
In this role, you will have the opportunity to lead a team of dedicated and high-performing scientists to direct the full life cycle of analytical assays for GMP release and characterization testing of our platform technologies of novel biotherapeutics. This role will lead a team responsible for assessing technologies to select methods to meet Quality Control needs, leading technology transfer to one of our GMP contract testing organizations, assessing feasibility, performing optimization at the partnering CTO, overseeing qualification, and examining method performance and trending to support ongoing method optimization and improvements. 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) to generate assays that are relevant and cutting edge. 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, 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:
- Next generation sequencing and it’s use in GMP environments to support virus genome sequence and variant analysis, adventitious agents detection, and mutanome mapping
- Cellular and molecular methods such as virus titering by plaque assay, genome quantitation by qPCR, impurity assessment by ELISA or qPCR, etc.
- 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
- Planning and leading assay qualification and validation according to principles in ICH Q2, especially as is appropriate to support early clinical development. Experience with method validation considered an asset.
- 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)
This role is best suited for a scientist with 8+ years experience in directly supporting analytical method development and qualification 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 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. 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 office 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 consideration will be given to anyone living in eastern North America who is able to travel on occasion (post COVID-19).