Ping Yin Email & Phone Number

Boston, Massachusetts, United States

Greater Boston Area

♦ Developed Regulatory CMC submission strategies and led the CMC submissions for global clinical trial applications♦ Collaborated with regional representatives to complete Model 3 in a marketing application in Australia♦ Provided regulatory assessment in change controls, deviations, and GMP investigations♦ Represented Regulatory CMC in a cross-functional group to design Global Regulatory Strategy Document and Health Authority Question database

Boston

♦ Developed CMC control strategies and led cross-functional CMC activities.♦ Authored CMC sections of regulatory submission, responses to regulatory agency’s questions, protocols, reports, and SOPs. ♦ Authored change controls, deviations, and GMP investigations and provide analytical assessments.♦ Managed CMOs for method development, transfer, and validation in support of drug substance and drug product release and stability.

Boston, Ma

♦ Authored methods, protocols, reports, specifications, shipping and storage documentations to support regulatory submission for NDA, IND, and IMPD.♦ Independently designed and performed analytical testing and effectively communicated data to support product development (three years for chemical drugs and one year for biologics).♦ Direct experience in method development, transfer, validation, investigation, and stability study to support drug substance and drug product development.♦ Mentored a Sr. associate scientist for one year.

Billerica, Ma

♦ Developed 1D/2D-LC-MS and LC-MS/MS methods (Waters UPLC, Agilent HPLC, or Dionex RSLC/RSLCnano coupled to Bruker ion trap MS or high resolution Q-TOF MS)♦ Analyzed customers’ samples (intact antibodies, top-down and bottom-up proteomics, PTM analysis, impurity analysis, synthetic small molecules, and natural products, etc.)♦ Demonstrated instruments and presented results to customers in industry and academia♦ Provided customer training and customer support

Urbana-Champaign, Illinois Area

♦ Studied peptidomes and secretomes of glial cells with multiple LC-MS techniques and bioinformatics tools.♦ Developed LC-MS based methods to identify and quantify (labeling and label-free) amidated peptides in mouse pituitary.♦ Characterized and quantified ectopic MII peptide in Drosophila heads with CapLC-ESI-IT MS/MS and CapLC-MALDI-TOF/TOF MS/MS to study the function of a transcriptional factor.♦ Investigated tandem MS of 5-mer peptides with NanoLC coupled to ESI-Q-TOF MS.

Urbana-Champaign, Illinois Area

♦ Supervised a diverse student population at beginner level to conduct chemistry experiments.♦ Monitored and assisted individuals’ progress by prompting and answering questions.♦ Demonstrated principles and procedures in chemistry labs.♦ Impartially evaluated student progress and provided timely feedback.

Ph.D., Analytical Chemistry

B.S., Chemistry