Mahesh Jayamanna

WORK HISTORY

EDUCATION

ABOUT MAHESH JAYAMANNA

QC Manager/Scientist led the lifecycle management of analytical methods in collaboration with AD/CMC teams by setting up Analytical Target Profile, strategizing phase-appropriate method qualifications/validations, and verifying the method performances over time with continuous monitoring.• Demonstrated leadership by leading the QC Chemistry team in various QC activities (i.e, method qualifications, oversight stability and release testing, conducting investigations, maintaining instrument qualification status, managing continuous improvements, and leading quality events, etc.).• Authored and reviewed method qualification/transfer protocols, reports, test methods, SOPs, deviations, and investigations resolving OOS and OOT events.• Collaborated with CMC teams in setting up DS/DP specifications, authoring and reviewing IND filing sections for analytical methods and method validations. Authored and reviewed responses to regulatory agencies. • Developed and qualified HPLC, CE, ELISA, LC-MS, and Spectrophotometric methods for AAV gene therapy product release, stability, and characterization testing.• Solid background in cGMP laboratory processes and leading quality events (i.e, deviations, CAPA, change controls, OOT and OOS).• Strong analytical expertise with HPLC, LC-MS, GC-MS, GC-MS/MS, GC-FID, UV-Vis, CE-SDS and other analytical instruments in method development, qualification and validation.• Developed GC-MS/MS MRM methods for the compound screening and characterization of microbial metabolites in complex mixtures of patient breath samples and in-vitro fungal and bacterial cultures.• Strong hands-on experience with GC-MS, GC-MS/MS and GC-FID method development, maintenance and troubleshooting of the instrument with GC column change, cleaning MS ion source and changing GC inlet consumables, etc. • Excellent written and verbal communication skills.• Experiance in leading external (CRO) method qualifications/validations, and managing release/characterization testing, being the key SME for multiple complex and compendial methods.