- Support CMC Specialists within the R&D department by taking responsibility for managing analytical methods used in protein characterization 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.
- 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.