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  • Location

    leiden, Netherlands

  • Job title:

    Project Manager CMC

  • Sector:

    Biotechnology

  • Job ref:

    43438

The company

Our client is a professional organisation, based in Zuid-Holland Netherlands. They are a Biopharmaceutical company that specializes in the development of vaccines to cure infectious diseases worldwide.

Role description

You will provide CMC Team support, CMC strategy, support Risk Management, work out scenarios to support decision making, manage the CMC end-to-end process, plan and manage the cross-functional project deliverables that support the CMC development and Commercial Launch. Furthermore you are responsible for Resource (FTE & OOP) and Budget Management and work in close collaboration with the CDT Program Management Leader to ensure alignment of the CMC strategy with the CDT strategy and PMT Program Managers to ensure alignment of functional strategies with the CMC strategy.

Responsibilities

  • Ensure Program and Strategic Planning
  • Leadership and Operations Management
  • Align to customers in the area of Product Development, Submission Management and Oversight
  • Provide Program Information and Communication Management
  • Responsible for Program Timeline, Resource and Cost Management

Requirements

  • BSc degree, MSc degree, MBA, PharmD or PhD degree in Life Sciences area or Business expert with more than 10 years relevant work experience
  • 5+ years of experience in the Pharmaceutical industry
  • Experience and knowledge of CMC development and regulatory, analytical development, Manufacturing, active Pharmaceutical ingredient and drug product development is a requirement
  • Project Management certification or degree (like PMP) and experience in developing a Health Authority is a plus
  • Fluent in English (oral and written), Dutch language is a plus

Other information

This is a fulltime job and you must be available on site at least 4 days a week, 32 hours is discussable.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.

Contact