Sr. Scientist - Small Molecule

Job Description

How You’ll Contribute: This position is within the Analytical Development team of the Applied Research department. This role focuses on developing, validating, and transferring analytical methods to support small and large molecule drug development and formulations from early-stage clinical studies up to commercialization. The position will establish, coordinate and monitor analytical related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The position also involves overseeing stability studies and conducting trending analysis for drug substance and drug product. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines. What You’ll Do: Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development. Troubleshoots and solves technical challenges in a timely manner and ensures generation of high-quality scientific data. Evaluates and interprets data from release and stability studies and provides scientific conclusions. Maintains expertise in cutting-edge assay technologies used for the characterization of drug delivery systems for drug release, potency, stability, impurity testing and aggregation profile. Prepares high quality experimental protocols and technical reports in support of regulatory submissions. Supports authoring appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions. Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robu