Analytical Development Scientist II

Job description

Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. The Scientist II role will support the development, optimization, and validation of analytical methods used to characterize small molecule drug products for early and late phase clinical R&D to support client GMP Clinical Release and Stability programs. The work performed in this role will help to shape analytical strategy, collaboration across functions, and deliver high‑quality data that enables the success of early/late phase clinical programs. Duties and Responsibilities: - Perform analytical testing such as UHPLC/HPLC, KF, Water Activity, Dissolution to support small molecules drug product development in GMP environment - Develop and optimize methods for drug products across early phase and late phase clinical stages - Execute method transfers to QC or partner labs, ensuring robustness and compliance. - Plan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑making. - Prepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documenta...