Description
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualifications * 9+years of experienced with protein (vaccine, antibody), peptide, oligonucleotide (siRNA) and small molecular drug analytical method development and validation * Experience in LC-MS detecting of API and its metabolites in blood, lymph and tissues proteins, antibodies, endogenous cytokines and glucose in blood * Expertise in LC-MS and HPLC troubleshooting, proficient in using Chemstation, Empower, Analyst, JMP software, and lab information system such as LIMS and sharepoint * Proficient in protein and peptide extraction, purification and quantitatively detection * Expertise in characterizing API in formulation and quality control: drug loading, solubility, drugs release (rapid and sustained), dissolution, and stability evaluation (short & long term stability, forced/accelerated degradation) Experienced with writing, assessing, developing protocols and reports with regulatory filings * Experience in leading and mentoring scientists and peers to solve problems * Published 20 peer-reviewed papers, 8 conference papers and 1 patents Work and Professional Experience Principal Scientist, Tergus Pharma LLC, RTP, NC Mar 2017 - present Team-leading essential projects from national and international clients, responsible for LC-MS method development and validation, protocol and SOP draft, in a GMP environment * Developing and validating bioanalytical methods using HPLC and LC-MS/MS, and using the methods for sample analysis for the quantification of small molecules, peptides and biomarkers in complex matrices * Support the analytical development efforts of multiple projects and perform review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards * Perform routine maintenance and troubleshooting for HPLCs and mass spectrometers, as well as implementation of strategies to minimize instrument down time, increase efficiency and productivity. * Manage multiple projects simultaneously, and communicating with study sponsors and business partners * Mentor colleagues and junior scientists
Accomplishments
Highlights:
Job Skills
Keywords
