· Management of contract drug substance and drug product analytical development and quality control activities and timelines
· Authoring and review of analytical method transfer and validation protocols and reports
· Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications
· Review stability protocols and monitor various stability programs
· Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
· Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs
· Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency