Vacature

CMC Program Manager

Vacature omschrijving

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.

  • Job Description

    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)

Eisen

    • 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 qualification 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, Power Point, 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.

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