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CMC Project Management Director, Gene Therapy

Dan Rodgers

Search Consultant - Pharmaceuticals, Biotech and Life Sciences

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Job Description

Our client, a rapidly expanding biotechnology organization within the commercial space, has tasked Pacific International to find an Director to lead their project management team. This position will work within their matrix structure to help develop their expansion into a new, exciting and innovative space within biotechnology. This position will be critical to supporting the growth of this new division and the company as a whole.

The primary focus of this role will be to for managing and aligning a cross-functional team with a matrix organization. This includes coordinating, assisting, and supporting all aspects of CMC projects to ensure each project is executed in a timely manner. This includes development, implementation, and execution of said timelines and strategies as well as assisting teams in developing their specific timelines and activities.

Outside of technical project tasks, this position will involve building and managing relationships with external manufacturers, ensuring they adhere to the aggressive timeline our client looks to uphold.

 

Key skills required:

  • Develop / Manage integrated CMC timelines across various programs
  • Ensure all CMC deliverables, activities align with the overall project plan
  • Ability to communicate with cross-functional teams and leaders
  • Identify project aims / scope as well as define quantifiable success measures
  • Define risks and implement risk management strategies
  • Develops and implements stakeholder management and communication plans
  • Engage stakeholders with solution-oriented focus
  • Present strategies and plans to senior management and governance forums
  • Manage relationships with and hold external manufacturers accountable
  • Foster culture of ownership and accountability including continuous evaluation, recognition, and process improvement

 

Desirable skills:

  • Understanding of vaccine or biogenic drug development
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment

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