Technical Integrator Drug Substance Development – Checkmark Labrecruitment – Leiden

JobID = 14n0.08

Do you have extensive pharmaceutical industry experience and excellent project management skills? Within this position you are responsible for the planning and execution of Drug Substance Development (DSD) project deliverables for the purpose of CMC projects. Are you curious to find out more about this position. Then, keep reading!

As a Technical Integrator Drug Substance Development you will lead the DSD project team and represent the team on CMC projects. Key responsibilities:

  • Lead a functional sub-team containing DSD representatives and Subject Matter Experts (SME)
  • Act as a single point of contact for the CMC team leader and Line Manager
  • Coordinate the departmental deliverables for one or more CMC projects in alignment with DSD line management
  • Develop the project strategy in consultation with the DSD department and CMC team
  • Ensure alignment with other functional areas like Analytical Development, Drug Product Development, Regulatory Affairs, Quality Assurance and Clinical Supply Chain
  • Budget preparation and generation of appropriate risk management scenarios
  • Ensure adequate technical review of regulatory submissions by the appropiate SME and consistency in content

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