Qc Analyst
Current-Perform specification testing on drug substance and drug product against 21 CFR part 210 and 211-Provide training to team members on new methods and instruments-Manage the distribution of pharmaceutical drug supply from depot to clinical sites for clinical trials-Compose and review analytical method validation protocols in accordance with USP and ICH guidelines -Initiate, oversee and preform analytical method validations-Write and review validation reports -Perform laboratory investigations in a quality control environment-Deliver CMC program updates for monthly and quarterly meetings-Collaborate with CDMOs to ensure proper release of drug product and drug substance -Develop and preform GMP assays on pharmaceutical drug substances and drug products-Develop, preform and maintain HPLC methods including ion-exchange, SEC, and normal phase chromatography -Experience working with contract manufacturing organizations to produce drug substance and drug product-Ensure continuous GMP documentation practices during quality sample testing