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  • Location

    Leiden

  • Job title:

    Technical Integrator (Analytical Development)

  • Sector:

  • Job ref:

    47240

  • Start Date:

    2021-12-11

The Company
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.

Role Description 
As an Analytical Development (AD) Project Manager you will represent AD in CMC projects, coordinate project deliverables and grow departmental expertise in CMC team. 

Responsibilities
- Represent AD in the CMC team and act as a Point of Contact 
- Lead functional sub-teams containing other reps and SMEs 
- Responsible for project deliverables at all CMC stages 
- Responsible for functional budget alignment 
- Develop the AD project strategy in alignment with other functional areas 
- Highlight gaps and or deficiencies in departmental functional strategies and or infrastructure and engage line management to address these gaps when conflicting/hindering project objectives.
- Responsible for successful functional process technology transfer to the plant/CMO including process-fit-to-plant activities.
- Responsible for maintaining oversight and control over activities at CMO
- Generating risk management scenarios to prevent project delays. 
- Ensuring that technical content review of Module 3 has taken place appropriately. 


Requirements 
- MSc or PhD in Life Sciences 
- Min. 8 years of experience in a biopharmaceutical drug development environment 
- Extensive experience in AD; method development and validation, interaction with regulatory agencies, ICH stability studies...
- Experience with vaccines and/or viral vectors 
- Project management 
- Able to lead multidisciplinary teams of professionals in a Matrix Environment
- Stakeholder management 
- Excellent communication skills in English  


Other Information 
For more information please contact GUilherme Tokunaga at g.tokunaga@sire-search.com or +31 (0) 20 658 98 01.