Associate Engineer, Manufacturing Operations (contractor)
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 an Associate Engineer of Manufacturing Operations on the MFG team, you will report to the Associate Director, Manufacturing. You will be tasked with supporting 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:
- Support manufacturing campaigns with external CMO partners
- Support manufacturing batch readiness including process definition, raw material procurement, and batch documentation preparation
- Support ongoing batch monitoring including person-in-plant coverage
- Support cross functional teams troubleshooting and resolving 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
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 Associate Engineer 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 a science, engineering, or biotechnology related discipline; MSc considered an asset
· 1-3 years’ experience in a technical operations or research/development role
· Experience with live virus based therapeutic manufacturing such as viral immunotherapies, vaccines, cell and gene therapies, or other complex biologics
· Experience with good manufacturing practices (GMP) in a clinical or commercial manufacturing setting
· 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 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.