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2/27/2017

Senior CMC Data Analyst

Global Responsibility

Support CMC Specialists within the R&D department by taking responsibility for managing analytical methods used in protein characterisation at internal and external labs, with specific focus on bio-functional/immunological/potency assays (cell based assays, binding assays including ELISA, MSD, SPR…). The senior CMC Data Analyst will assist assays development at 3rd parties labs, plan and assess qualification/validation of assays, assist in troubleshooting as required, monitor assays performance and suggest/implement improvements as may be appropriate, critically assess results obtained and seek clarifications whenever required. The senior CMC Data Analyst will report and critically discuss results in internal reports.

Specific Responsibilities

  • Plan and assess qualification/validation of bio-functional assays.
  • Assist in troubleshooting issues with bio-functional assays
  • Monitor assays performance by identifying, analyzing and interpreting trends or patterns in assays and suggest methods improvements as may be appropriate
  • Interpret analytical data and analyze results using basic statistical techniques (including detection of out of trend results).
  • Critically review third parties reports, request complementary information and seek clarifications as required.
  • Oversee specific third parties activities and ensure project progress
  • Together with the support of Junior CMC Data analysts, report data and critically discuss results in internal reports and presentations.
  • Look for scientific literature to support/illustrate findings.