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Experience with Analytical Pharmaceutical development, Quality control, protocol, qualification, verification, validation, and transfer of analytical methods. Forced degradation, stability indicating method. SOP. QC, QA, Analytical for Process Development. Formulation and formulation analysis. Polysaccharide, Vaccine, Antibody, Polymer, Macromolecule, Protein. Protein crosslink, protein activation, conjugation to polysaccharide and Oligosaccharide.
Acid analysis, Protein Enzyme Degradation characterization, Nucleoside Oncology Hsp90 inhibitor Patent, Research, Analysis, Synthesis. IND. CRO, CMO management, managed Cetek global CRO, CMO chemistry, hands on analyzed many CRO, CMO samples, including method development and validation with guidance for industry.
HPLC, GPC, GC, UPLC, LC-MS, LC-MS/MS, Advanced 600,500MHz NMR with Cryo Probe, UV, ELSD, Fluorescence, FTIR, Osmometer, KF, SEC-MALs, UFDF, AKTA, BCA, HPAEC-PAD, CE, SDS-PAGE, Waters Micromass Quattro Ultima. SQD. Agilent 6430, AB SCIEX Q-star, Triple Quad API4000 and 4000Qtrap LC/MS/MS.
GC5890, GC6890 volatile analysis. 2018 Agilent New HPLC purchase and training. Clinical and preclinical samples. Achiral/chiral HPLC, Supercritical Fluid CO2 Chromatography (SFC). LC-MS/MS MALDI-TOF PS Protein Analysis.
BECKMAN PA800+ CE-SDS. Quantitation using LC/MS and LC/MS/MS (API 4000 and API 4000 Qtrap), hands on finished lots GLP and Non GLP quantitation with LC/MS/MS MRM, DMPK-TOX projects. Immobilized enzyme (Fumarase) research and Analysis.
ELISA, DNA, RNA, DANase, RNAse, Peptidoglycan, liposome, hydrogel, nanoparticles analysis. LNP lipid nanoparticle formulation and analysis. Exenatide/Bydureon Impurities Analysis. Cyclosporin and Sanglifehrin.
C Diff and Pneumococcal polysaccharide vaccine isolation, purification, structure elucidation, structure modification, conjugation. General knowledge of organic synthesis and mechanism, designed and managed lots synthesis.
Validation. QC analysis. GLP, GMP regulations and 21 CFR Part 58. Got FDA GLP/cGMP, ICH/ISO 17025, A2LA, Accelrys ELN (Electronic Lab Notebook), CMC, cGMP, QC, API, CAPAs, OOT/OOS and Bioanalytical GLP training with training certificate.
Scientist II - Organogenesis - Canton, MA
(2024-09)
Analytical Development and Research development, Quality control chemistry, product QC Chemistry analysis, new method development and optimization, qualification and validation protocol and final report. Company new analytical methodology and instruments strategic planning support.
Sr. Scientist - CuriRx - Wilmington, MA
(2023-09 - 2024-09)
Drug Substances and Drug Product Formulation. Research and Analytical Development. Quality control, Analytical chemistry, medicinal chemistry, HPLC, UPLC, ELSD, CE-SDS, mAb, formulation mixture, Large and Small molecules analysis.
Sr. Scientist - Eagle Pharmaceutical - Cambridge, MA
(2020-10 - 2023-08)
Drug Substances and Drug Product Formulation. Research and Analytical Development. Quality control, Perform analytical chemistry, medicinal chemistry, HPLC, UPLC, GC-HS, GC, ELSD, HRMS, UV, Particle size analysis, microscope. Fulvestrant new formulation analysis.
Scattering, KF, Cal02 CHL, ESM, LNP structure and function, impact of LNP composition and process analysis, pioneer method, training scientists. Perform raw material, in-process finished product, and stability sample analysis. method validation/transfers. stability testing. troubleshooting methods and equipment.
Sr. Scientist, Analytical Technology, MSAT, Manufacture Science and Technology - Pfizer - Andover MA
(2019-05 - 2020-10)
Biologics and Vaccine assay development and testing, In Process impurity analysis, Quality control, Protein, RNA, DNA. CFB, UFDF123, DSI Process investigation, SEC-MALs Molecular Weight /Size determination and purity analysis Assay. OOS, OOT, Root Cause Analysis.
Polysaccharide structure and functional group analysis, Upstream and downstream sample analysis, sample pretreatment and related reaction mechanism investigation. Set Analytical strategies, help manufacture scientists solve in-process problems.
Senior Scientist, Analytical and Bioanalytical Chemistry, Research & Development - Matrivax Research & Development Corporation - Boston MA
(2014-01 - 2019-12)
Develop Analytical methods in support of the development of Matrivax New Vaccine Products. Polysaccharide and Protein Vaccine Product isolation, purification, structure elucidation, structure modification, conjugation. Hands on developed Matrivax PCMV (Protein Capsular Matrix Vaccine) product SEC-MALs Molecular Weight /Size determination and purity analysis Assay, Microbiology Product NMR Structure Elucidation at Company meeting. Formulation and Formulation analysis. Vaccine product analysis. Protein crosslink, protein activation, Protein conjugation.
Enzymatic degradation analysis and acid hydrolysis analysis. Successfully synthesized Microbiology C. Diff. Polysaccharide PSII, Pneumococcal Polysaccharide PPS19F CDAP protein conjugation products, C. Diff. Oligosaccharide PSII, PSI and Protein squarate conjugation products, model compounds synthesis and parallel synthesis, developed practical analytical assay to monitor conjugation reaction process and final product formation. Final product isolation and characterization. Hydrogel and LNP lipid and matrix polymer formulation research and analysis.
Postdoc. - Chemistry - Columbia University
Ph.D. - Chemistry - University of Alberta
M.S. - Microbiology Pharmacy - PUMC (Peking Union Medical College) & CAMS (Chinese Academy of Medical Sciences)
