CMC Project Manager – VectorY
Work for an organization that brings innovative therapies to patients worldwide
VectorY combines the potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for disease areas of high unmet medical need. Founded in August 2020, and based in the Amsterdam Science Park, VectorY is a fully integrated gene therapy company focused on the development of innovative therapeutics. With R&D and manufacturing facilities in Amsterdam, VectorY develops proprietary & partnered programs based on its novel AAV-based vectorized antibody gene therapy platform. Product candidates are based on next-generation vector technologies, which will enable a proprietary and highly scalable manufacturing process within VectorY’s own manufacturing facilities.
VectorY is seeking a highly motivated individual to join us as a CMC Project 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 the 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 management 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 advanced collaboration
- Provide effective communication and coordination with operational teams and proactively update stakeholders on progress and issues (e.g. project dashboards, reporting)
Skills and qualifications
- Masters’ degree in a relevant field with a strong technical background and a minimum of 5 years experience in project management in the biotech or pharmaceutical industry.
- Project management qualifications such as PRINCE2, PRINCE2 Agile, PMP, APM Associate, PMQ is desirable
- Experience managing multiple projects simultaneously and resolving conflicts related to meeting numerous deadlines
- Knowledgeable with the drug development process, gene therapy industry
- Proficient in MS Word, Excel, PowerPoint, Outlook, Teams, and MS Project; SharePoint; and document formatting tools experience a plus
Your natural strengths and drivers
- Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
Working at VectorY
We offer a personal and authentic experience within a young, ambitious biotech company on the path to bring innovative therapies to patients worldwide
For more information about this vacancy contact Managing Partner Albert Peters + 31 6 28209882or send your cv to firstname.lastname@example.org