Manager, Formulation and Drug Product Development
Turnstone Biologics Inc. is the leading virus-based immunoncology biotechnology company developing novel oncolytic vaccine therapeutics for cancer patients. Our first-in-class platform technology attacks tumours using a two-pronged approach: targeted and robust tumour killing using an oncolytic virus, in combination with a cancer vaccine that generates long-lasting anti-tumour immune responses. Turnstone is building a world-class, high-performing team 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, Canada and New York, USA. For more information, please visit www.turnstonebio.com or email firstname.lastname@example.org.
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 Thursday 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.
If you are interested in being a part of a growing Technical Operations team, then this role may be for you! As the Manager of Formulation and Drug Product Development, you will provide leadership, plan, direct, and coordinate all Drug Product development efforts to support our viral-based platforms. Reporting to the Director of Bioprocess Development & Manufacturing Sciences, you and your team will be responsible for:
· Manage DP development for entire portfolio of viral products
· Plan and direct lab experiments, with 1 reporting FTE by end of 2019
· Manage DP development at our external CRO partners
· Drive development of improved viral delivery systems (IV infusion, IT or IM injections) to enable optimization of pharmacy DP handling and administration
· Work closely with the Analytical Development team to ensure appropriate and robust assays are developed to enable stability testing of our DPs
· Lead all aspects of pre-formulation and formulation development across a range of DP images (liquid, and lyophilisation)
· Drive to definition of DP critical quality attributes through forced degradation studies and advanced analytical tools
· Travel required, 10%
· Participation in regulatory strategy and document authoring/reviewing for interactions with FDA, EMA, and Health Canada
· Present trended data, and recommendations in a cross functional Project Team
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 opportinites 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.
This role is best suited for someone with the following:
· 7+ years of overall experience within the biotech/pharmaceutical industry
· Scientist with advanced degree (MSc or PhD)
· Educated in one of the following fields: chemistry, biochemistry, virology, biotechnology
· Experience working with live virus formulations
· Experience designing, and planning accelerated studies to evaluate degradation pathways to define CQAs
· Strong interpersonal skills, and ability to manage several projects
· Leadership experience preferred
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.