01Overview
Product characterization using LC/MS for biosimilarity studies.Training related to advanced LC-MS applications and DQA SOPs.Planning of experiments.Drafting and/or review reports and presentations on experimental data and scientific outcomes for CMC / RA for dossier submission, method qualification, assessing biosimilarity etc. Guiding and mentoring team members Sample preparation, LC-MS workflows and data interpretation.Support cross-functional analysis such as impurity characterization.Method Development, Qualification and report preparation.Procurement related to new instruments. To assess new technologies to enhance in-house scientific and technological capabilities.Comply to quality aspects (CAPA, CC, Deviation).Comply to safety norms and attend safety training. .
