Senior Research Scientist
New Haven, Connecticut, United States
▪ Leads analytical method development and GMP validation in accordance with ICH guidelines, methodologies include ELISA, qPCR, ddPCR, CE, HPLC, and gel-based techniques▪ Manages multiple biopharmaceutical clients and respective products ranging from pre-clinical to commercial phases▪ Implements and leads process improvement strategies to reduce validation and development turnaround times▪ Writes GMP investigations and nonconformances ▪ Participates in regulatory audits, past… Show more ▪ Leads analytical method development and GMP validation in accordance with ICH guidelines, methodologies include ELISA, qPCR, ddPCR, CE, HPLC, and gel-based techniques▪ Manages multiple biopharmaceutical clients and respective products ranging from pre-clinical to commercial phases▪ Implements and leads process improvement strategies to reduce validation and development turnaround times▪ Writes GMP investigations and nonconformances ▪ Participates in regulatory audits, past experience includes HPRA and PMDA audits▪ Mentors and trains new technical project leads and subject matter experts in general GMP practice, project management, method validation, and method development Show less