Perlapati Sivalingachari

WORK HISTORY

EDUCATION

ABOUT PERLAPATI SIVALINGACHARI

Working on Complex Injectables, Protein, Peptide Analytical Development, Validation, Transfer, Stability Studies & characterization and Analytics for Biosimilars • Expertise in Analytical method developments, validation transfer of various analytical tests for Complex Injectable formulations including Proteins, Peptides, lyo products, Injectable suspensions and Ophthalmic Products. using Various Analytical Techniques • Impurity Profiling of Various Drug Products. • Responsible for In vitro Method development and Validations Using Various Types Of USP Dissolution Apparatus • Amino acid analysis of Peptides, Proteins. • Protein conformation, structural analysis of biomolecules, & Secondary Structure Characterization of Peptides, proteins using CD • Technology transfer from R&D to Quality Control of manufacturing site. • In-process support to upstream, downstream and cell line development. • DS and DP characterization, DS and DP stability. • Worked on multiple projects, proteins, peptides (rDNA Technological derived products, peptides). • Hands on experience and Provide analytical support for methods like HPLC and UPLC - SEC, IEX,CD, MALS - SEC-RI/MALS, UV Spectrophotometer. • WRS/Reference standards development. • USP General Chapters, USP, EP monographs and ICH guidelines. • Quality notifications (Deviation, Incident, change controls, change request, CAPA, OOS and OOT). • Having experience working under GLP, GDP and GMP environment. • Experienced with EMA, USFDA and internal audits. Skills Expertise in characterization study by HPLC, UPLC, SEC, GPC, SECMALS, CD, IC, for Complex Injectables,Proteins, Peptides, Monoclonal antibodies etc. Expertise in Method Development and validation for Various Complex Injectable dosage forms, Proteins,peptides e.t.c Ability to develop and validate analytical methods for Complex Injectable Dosage forms, Proteins and peptides Expertise in Method Development. Validation, Regular analysis like collaborative study for Complex large molecules. Expertise in review of protocols and Reports. Statistically interpretation of analytical results. To ensure compliance of various quality measures and maintaining appropriate requisite documentation records.