VectorY is seeking a highly motivated individual to join us as a CMC Program Manager to align all functional areas in their mission to deliver novel AAV-based vectorized antibodies. This position will provide business operations, project management, and regulatory filing support to the Project Management team in a dynamic and fast paced organization.
The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Research, Vector & Process Development, Quality, Supply Chain, Manufacturing, and Regulatory Affairs teams.
Although CMC program management will be a majority of the PM’s responsibilities, the scope of the position will be boarder than CMC and will encompass managements of activities, budget and planning outside of CMC (such as (pre)-clinical and regulatory activities etc).
Main responsibilities of the role
- Drive cross-functional (CMC) program teams (with members from Research, Vector Development, Analytical Development and Process Development departments) and manage deliverables for on-time completion
- Develop and maintain CMC plans, materials for strategy development and prioritisation (e.g. Gantt charts, Visio process maps), risk management strategies and risk / issue logs, meeting minutes, decision and action item logs, etc.
- Partner with Technical Operations departments to ensure coordinated preparation and delivery of materials and regulatory submissions
- Manage and coordinate various program-related outsourced activities at CRO’s/CDMO’s
- Oversee adherence to program budget items
- Foster productive communication and alignment among all functional areas, as appropriate, via proactive networking and facilitation
- Develop, deploy and support the optimization of business processes and tools to improve efficiency and advance collaboration
- Provide effective communication and coordination with operational teams and proactively update stakeholders on progress and issues (e.g. project dashboards, reporting)