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Associate Director, Analytical Development and Clinical QC

Company

Alexion Pharmaceuticals

Location

New Haven, United States

Type

Full time

This position will play a key leadership role in Alexion’s Late Stage Analytical team, which requires analytical expertise and proven success in management of development projects through the CMC lifecycle. This position will lead multiple projects in parallel and working closely with other PDCS teams, Regulatory, QA and external QC laboratories as a lead to designing the strategy of late-stage analytical activities including method transfer/validation, compendia method verification, and overall testing strategy throughout all phases of the product lifecycle. Moreover, this position will lead to authoring regulatory filing in relevant analytical sections with a focused understanding of country-specific requirements!

You will be responsible for:

  • Leading all aspects of analytical method validation, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages
  • Analytical lead for CMC programs, emphasizin...
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