Chinn Emeahara Email & Phone Number

San Jose, Ca, Us

San Jose, Ca, Us

Menlo Park, California, United States

Served as cross-functional drug product development team’s led scientist. Oversaw analytical research and development of assays for qualitative and quantitative of API in product, including filling of NDA to FDA. • Supported clinical assessment by leading design of experiment of ATPs used for analysis of active pharmaceutical ingredient (API) content, related substance assay, excipient, product impurity, in-vitro dissolution, leachable characterization, qualification, work instruction, and validation reports.• Supervised and contributed to in-vitro dissolution assay profile development, lot release, process scale-up, product stability testing, assays and instruments troubleshooting, ATPs transfer, QC associates training, and regulatory requirements studies.• Ensured ATP’s, qualification, validation, report accurately prior to NDA submission by reviewing documents and analyzing data.• Reduced downtime and ensured compliance by managing cGMP equipment preventive maintenance, calibration, change control, and other quality systems.

Emeryville, California, United States

Led cross-functional team to develop and support commercial protein and antigen manufacturing. Conducted chemical analysis and characterization, qualitative and quantitative analysis, peptide synthesis, process scale-up, assays process development, qualification, validation, and report preparation. • Facilitated timely technology transfer to manufacturing QC by leading diagnostic peptide synthesis (40+ amino acids sequence), purification, chemical analysis, characterization, process scale-up, preparation of SOP’s, work instructions, qualification, validation, and reporting.• Led process development for genetic engineering of yeast strains saccharomyces cerevisiae proteins, including design of experiment (DOE) for total proteins qualitative and quantitative analysis, chemical characterization, bulk fill, improvement, qualification, validation, reports, and technology transfer to manufacturing QC.• Supported manufacturing by leading root cause analysis, failure modes and effects analysis (FMEA), process improvements, proven acceptable range (PAR) studies, lifecycle qualification studies, and regulatory requirements deviation and unanticipated events investigations.

Menlo Park, California, United States

Functioned as lead scientist for cross-functional formulation, AR&D, and product selection groups. Conducted exploration and feasibility studies and selected API for pre-clinical phase development.• Guided development of assay methods and procedures - API extraction, qualitative and quantitative of API content in formulation, related substances, excipients, in-vitro dissolution, troubleshoot assays and instruments, QC analysis, qualification, and report. • Supervised cGMP equipment calibration, preventive maintenance, change controls, and other quality systems, decreasing downtime and verifying compliance.