Program Manager, Technology Transfer

Hillerød, Denmark

FUJIFILM Diosynth biotechnologies in Hillerød, Denmark is looking for an experienced Project Manager to join the Program management and Technology Transfer organization.

Program management and Technology Transfer is a core function within PS. We are a growing team of 4 highly professional dedicated program managers with broad experience within pharmaceutical development and manufacturing of mainly mAb’s.

Program management and Technology Transfer is an organization embedded in the Process Science (PS) organization which is a department that provides scientific leadership to support clinical, PPQ and commercial processes in large scale Cell Culture manufacturing, Assembly, Label and Pack (Finished goods) and within a few years Drug Product too.

We lead Technology Transfers (TT) including the teams and as technical program leads maintain an overview of TT progress and at the same time look out for process compliance to filings, (CMC). We continuously strive to identify opportunities to improve systems and practices, and provide direction to our manufacturing group as well as technical development teams and our customers.

The work environment is informal, where we strive to have a lot of fun, while we keep a high pace.

Your main responsibilities

  • Manage Technology transfer activities for clinical/PPQ and commercial products into large scale manufacturing facility
  • Develop PPQ strategies specific for different programs for large scale
  • Develop projects plans that integrates with other scheduling functions within the organization
  • Ensure cross functional communication to key stakeholders for any given project/task and that input are received
  • Work in conjunction with key stakeholders/project team/s to develop and gain agreement on metrics
  • Implementation of continuous improvements
  • Proactively informs Senior management/Site Leadership Team of milestone progress and any upsetting program delays
  • Coordinate and lead regular planning with key stakeholders
  • Ensure project execution is performed in compliance to existing procedures
  • Ensure deliverables from process leads (e.g. Process Validation reporting) to regulatory filings. Communicate review and approval timelines to management
  • Execute on and support process trending and continued process verification plans.  Review and document process performance and product health through process trending, monitoring, and supporting annual product reviews

About you

  • You have a Master degree in Biochemical or Chemical Engineering or a BS/BA in a scientific or engineering field
  • Minimum 5-7 years relevant industry experience
  • 2-3 years of experience with Project management preferably as Tech Transfer or CMC Project Manager
  • Demonstrated successful Project Management skills
  •  A solid understanding of Biopharmaceutical manufacturing and GMP (Experience in either Cell Culture and/or Protein Purification)

You have the ability to evaluate complex matters and identify key stakeholders. You pay attention to both the detail and the bigger picture. You are e high performing team player, ambitious on behalf of yourself and the company. You have the ability to balance between speed of execution and quality of work

We are reviewing applications on a continuous basis and urge you to apply as soon as possible.


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Mere af samme slags?

Modtag jobannoncer der minder om dette job i din indbakke.




Når du tilmelder dig accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.

Andre job der matcher din søgning

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FUJIFILM Diosynth biotechnologies in Hillerød, Denmark is looking for an experienced Program Manager Process Sciences to join the Program management and Technology Transfer organization. Program management and Technology Transfer is a core function ...
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