Job opening

CMC Program Manager

Location

Amsterdam

Job description

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)

Qualifications

  • 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

Interested? Apply directly!

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