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Associate Director, Analytical Development and Clinical QC

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Alexion Pharmaceuticals
πŸ“ New Haven, United States
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Location New Haven
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Posted June 12, 2026
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Commute Local Area
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Job Description

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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    πŸ“ Location Details

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    City
    New Haven
    πŸ—ΊοΈ
    Country
    United States
    πŸš—
    Commute
    Local Area

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