Turnstone Biologics’ mission is to deliver breakthrough immunotherapies to improve survival for people with cancer. Our first-in-class platform technology is a disruptive class of engineered viral immunotherapies, attacking cancer’s complexity with medicines designed to fight tumors at multiple points of intervention, including simultaneous generation of targeted immune responses and modulation of the tumor environment. Turnstone is building a world-class, high-performing CMC team that embraces being a learning organization with a sense of urgency, where CMC is a differentiator and enabler rather than a cost-center. 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 email@example.com.
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 Tuesday 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 technologies are complex and transformative. If you’re a passionate person and our science excites you – this opportunity may be for you.
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:
- 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.
- In depth knowledge of the methods, instruments, and regulatory considerations of next generation sequencing and it’s use in GMP environments considered an asset
- 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)
This role is best suited for a scientist with 8+ years experience in directly leading [AF1] 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).