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? As the Associate Director of Formulation and Drug Product Development, you will provide leadership to a team of Scientists, drive the strategic development plan and direct all Drug Product (DP) and formulation development efforts to support our viral-based platforms (RIVAL). Reporting to the head of viral development, you will: · Participate as an active member of the Viral Development leadership team, to support overall analytical and process development needs across Drug Substance and Drug Product development · Manage a cross-functional matrix team (Clinical, Supply Chain, Regulatory, Quality, Tech Ops) to develop overall Drug Product development strategy for a suite of viral-based products · Provide leadership and guidance to a small team of Scientists · Drive development of improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration · Develop and drive the overall stability program strategy at all key stages of manufacture · Work closely with the Analytical Development team to ensure appropriate and robust assays are in place to enable stability assessments, and drug product characterization · Lead all aspects of pre-formulation and formulation development across a range of DP images (liquid, and lyophilization) · Drive to definition of DP critical quality attributes through forced degradation studies and advanced analytical tools · Support biophysical analytical development and design of characterization studies · Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, Health Canada, MFDS, and other jurisdiction as they emerge 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 Details Turnstone Technical Operations is a virtual organization, where nearly all of our wetbench work is executed at third party CMO/CRO partners. We have offices in Ottawa, Canada and San Diego, USA and ideally you feel motivated to relocate for this role to one of those sites. Most of our virus development team is stationed in Ottawa Canada, and most of our partnerships are in Europe – therefore relocating to Ottawa would be ideal, but if you feel you can be successful from San Diego, then let’s chat! This role is best suited for someone with the following: · 8-10 years of overall experience within the biotech/pharmaceutical industry · Minimum of 3 years of leadership experience demonstrated as either having direct reports, and/or demonstrated leadership across complex projects and cross functional teams · Scientist with advanced degree (PhD strongly preferred but not required) · Strong interpersonal skills required · Experience developing and/or interpreting biophysical analytical methods · Expertise developing novel formulations (experience developing live virus formulations considered a very strong asset) · Experience working with drug transfer devices and planning pharmacy handling procedures · Expertise managing stability programs, including knowledge of relevant regulatory guidances, considered a strong asset · Educated in one of the following fields: Biochemical Engineering, Biological/Biomedical Engineering, Virology, Biology, or Biochemistry · Experience designing, and planning accelerated studies to evaluate degradation pathways and define CQAs · Excellent computer skills, including Microsoft Excel and Powerpoint · Able to manage competing priorities effectively and adapt to changing priorities · Self-motivated and efficient, able to manage responsibilities with an appropriate sense of urgency, and function effectively in a fast-paced and dynamic environment · The candidate must exude a mature communication style that matches the Turnstone style: respectful, transparent, with a high degree of integrity and humility 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.