Team Objectives : Developing, qualifying and validating analytical methods that will be used for protein characterization, as well as Drug Substance / Drug Product lot release testing according to relevant ICH guidelines and GMP regulations Sub Projects : 1. Physicochemical analytical method development 2. Biologics analytical method development and characterization Essential Job Functions (listing most important first): 1. Analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for the global biosimilar or biologics programs 2. Analytical method development and method validation experience for biologics - GMP QC lab experience: > 3 years - Experience for method transfer activity - Method validation protocol & report experience 3. Physicochemical characterization for biologics - Experience for protocol/report of characterization study 4. Stability study manager for biologics