Scientist - I (Process Expert) – Late Stage CMC

Scientist - I (Process Expert) in Late Stage CMC leads technical scale-up, process risk assessment, and technology transfer to enable robust, reproducible manufacturing for submission and commercial supply. Works with CMC, QA, and RA teams; coordinates with external manufacturing sites (CMOs/CDMOs); drives late-stage CMC deliverables, design space and control strategy definitions, and preparation of protocols, reports, and validation plans. Engages in new product launch activities, identifies suitable CMOs/CDMOs, and supports continued product supply while interfacing with internal and external stakeholders to promote best practices in pharmaceutical technology and regulatory readiness.