Turnstone Biologics Inc. is the leading virus-based immunoncology biotechnology company developing novel oncolytic vaccine therapeutics for people with cancer. 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.
What would it be like?
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.
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 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 a
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.
How do you know if you’re the right fit?
· This role will be formally positioned out of our New York, NY office but working from home/remotely will be the normal
· Willingness to travel (when it’s safe as it pertains to global pandemics) up to 10-30% 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
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.