Sudipta M.

Director, Analytical Sciences (Cmc) @Xencor

Analytical: Accountable for technical oversight and phase-appropriate development, qualification/ validation, re-assessment, and transfer of chromatographic, biophysical, electrophoretic, and immunological methods targeted for in-process, release, and stability testing of early and late-stage protein therapeutic development programs.– MTech: Oversee characterization and data analysis to support research activities on antibody research and development to improve yield, purity, and stability. – Regulatory: Prepare and review documents in support of CMC regulatory filings and writing responses to health authority questions. – Compliance: Contribute expertise on data interpretation, applications, instrumentation, and trouble shooting. Advances analytical testing capabilities through CDMO and partner groups. Review documents in support of CMC regulatory filings and writes responses to health authority questions.– Administration: Managing Team. Budgeting. Works closely, as a multidisciplinary project team member, with internal, and external collaborators. Provides expertise, technical leadership, and assessment of product quality impacting non-conformance and out of specification investigations.