Hands on experience of QTOF, other HRMS and TQ LC-MS techniques.
Complete, in-dept knowledge on Proteomics and Biosimilars characterization (Intact mass analysis, peptide mapping, PTM analysis, etc) using LC-MS/MS.
Knowledge on Sample prep for Mass Spec
Experience on method development and qualification for various mAb s using LC-MS/MS.
Characterization of SSR/Signal peptide
Knowledge on ICH guidelines
To ensure implementation of SHE and QMS at work place.
To draft the study protocols, method development reports, comparability reports and CMC sections of regulatory documents
Maintenance of laboratory as per the cGLP.
Having the good writing, presentation and documentation skill
Understanding on good laboratory practices and Good Documentation Practices.
Education & Experience :
MSc/M.Tech with minimum 2-6 years of working experience Method development, qualification, Handling of analytical instruments like HRMS, TQ LCMS, Synapt, Xevo QTOF, etc