Narsireddy Amreddy

Method Validation Scientist @Cytovance Biologics

OK, US

Spearhead analytical method development, validation, verification, and transfer for the characterization of excipients (Proteins, Enzymes, Antibodies, Polysaccharides etc.), drug substances, in-process samples, and drug products in compliance with cGMP guidelines.• Plan, draft, and execute method validation, transfer, and verification protocols, alongside the preparation of comprehensive reports per cGMP standards.• Apply extensive knowledge of FDA, ICH, and USP guidelines to ensure regulatory compliance.• Extract RNA, DNA, and proteins from cell lysates and animal tissues, applying advanced molecular techniques.• Develop, validate, and verify methods for quantitation using qRT-PCR.• Conduct qualitative and quantitative analysis of excipients and in-process/finished product samples using state-of-the-art quality control techniques, including RP-HPLC, SEC-HPLC, SEC-MALS, Nanodrop, CE-SDS, cIEF, SoloVPE, BCA, HCP, and ELISA.• Train and mentor new and existing laboratory personnel, including Research Associates.• Troubleshoot, maintain, and calibrate a variety of analytical instruments, performing routine qualifications to ensure accuracy and reliability.

CSIR-Indian Institute of Chemical Technology and Center for Cellular and Molecular Biology

Doctor of Philosophy (PhD), Nanomaterials, Characterization and Diagnosis, Drug Delivery, Nanomedicine

Osmania University

Bachelor's degree, Chemistry, Physics and Mathematics

Osmania University

Master of Science - MS, Chemistry