BrightOwl Loader Loading

Senior CMC Data Analyst - Spain  

Company managed [?] Still accepting applications
106 Facebook  Linkedin

Posted on : 13 April 2017

Project Description

Global Responsibility 
  • 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. 

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.