Turnstone Biologics Inc. is the leading virus-based immuno-oncology biotechnology company developing novel oncolytic vaccine therapeutics for cancer patients. Our first-in-class platform technology attacks tumors using a two-pronged approach: targeted and robust tumor killing using an oncolytic virus, in combination with a cancer vaccine that generates long-lasting anti-tumor 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.
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.
Responsibilities include, but are not limited to:
- Translate Clinical Development Plan requirements into an actionable end-to-end supply plan, evaluating multiple different scenarios at a time
- Serve as the primary interface with Clinical Operations, Quality, Regulatory Affairs, Manufacturing Operations and Process Development/Manufacturing Sciences to ensure coordination of all activities necessary to develop the forecast and ensure an adequate supply plan
- Lead internal cross-functional team on execution of project timelines and coordinate labeling, packaging, and shipment of packed supplies with external suppliers
- Manage and maintain IMP distribution and return drug plans and manage any documentation associated, in compliance with GMP and industry standards
- Monitor inventory levels as well as expiry and re-supply needs; communicate needs and de-risk as appropriate across the entire supply chain (bulk drug substance through IMP supplies)
- Promptly identify and escalate risks to study timelines or clinical supplies, from a supply chain perspective, to all key stakeholders
- Support implementation of and utilize systems to effectively manage key product/project activities
- Articulate clinical supply chain management processes and strategies to key stakeholders
- Review and update existing procedures and SOPs; identify the need for and assist in the establishment of new procedures and SOPs
Requirements include, but are not limited to:
· Advanced degree in Life Sciences, Engineering or Business
· 3-5 years of experience in Clinical Supply required, along with a strong understanding of GMP and GCP
· Experience with using and implementing an ERP system (Oracle, SAP or NetSuite)
· APICS CPIM / CIRM certification preferred
· Knowledge of import/export regulations, including pro-forma invoice generation, import regulations and global trade compliance
· Experience working with third-party CMO clinical supply operations
Additional skills/experience needed are:
· Must possess exceptional communication skills, self-motivated and have exposure and/or knowledge of software programs including Microsoft Excel, Interactive Response Technology (IRT) and ERP systems
· Willingness to learn and sense of urgency to meet patient and program needs
· Strong ability to work closely with all disciplines within a small company, displaying innovative thinking, motivation, and accountability