Charlotte Tsang

•Lead the development, qualification, and transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, proteins, polysaccharide-protein conjugates, large aggregates, in-process small molecule impurities, and vaccine targets •Manage and lead an analytical ~5 chemists sub-team, provide technical direction, mentorship and coaching •Cultivate a cohesive, innovative, motivated, and productive team environment to ensure deliverables, job satisfaction, and achieve key results •Develop analytical methods and conduct characterization studies to support process and formulation development (up-stream and down-stream) and the establishment of appropriate manufacturing control strategies •Manage and oversee stability studies of starting materials, intermediates, drug substances, and drug product of conjugated vaccine projects. This includes stability protocol preparation, stability set-down, samples analysis, stability data analysis and trending, and stability report issuance •Perform analytical method transfer to CROs/CMOs; oversight CROs/CMOs by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs, as well as trouble shooting and analytical investigation at CRO/CMOs •Evaluate innovated and cutting-edge technologies with vendors to bring in analytical systems in-house to streamline internal workflow, overcome analytical challenges, and support fast-pace conjugated vaccine project •Author protocols, reports, and regulatory submissions

•Conduct experiments, such as stability study, release testing, and method development and validation to support multiple projects filing IND to FDA and pre-clinical, and clinical studies - phase I/II/III •Perform technology transfer, data and site audit, evaluate, and manage CMO •Perform regulatory filing for pre-IND to late-stage projects •Participle in CMC committee, such as communication with cross-functional groups, risk management, PAR evaluations, feedback on timelines, analytical representative, and spec. justifications •Conduct chiral and achiral HPLC and LC/MS methods for new drug substances and products to support multiple projects •Experience (SME), oversee and maintain multiple UHPLC screening systems which coupled with different orthogonal detectors to overcome analytical challenges •Experience (SME) on two-dimensional HPLC with different applications for challenging compounds •Support cross-functional groups such as discovery, process, formulation, and analytical division on new drug substances and drug products HPLC and LC/MS analytical method development, forced degradation study, excipients compatibility study, and GMP stability study •Develop SEC method by MALS/RI for polymers, large aggregate, and oligomers •Partner with QA team for validation protocol, OOS investigation, and external audit •Draft, review, and validate SOP Ion chromatography, HPLC, and dissolution method •Responsible for implementing and evaluating necessary method development platform, software, and data analysis tools •Manage staffs to ensure safety compliance and zero violation •Manage HPLC/GC column, lab and instrument consumables expenses and budget control •Conduct small molecules characterization using different technologies, such as HPLC, LC/MS, HSGC, FT-IR, KF, Particle Size, dissolution study and DSC/TGA

•Prepare calibration standards, reagents, hydrocarbon, additives, and catalysts samples accurately and sufficiently •Able to pre-treated samples (i.e. acid digestion) before run on different instruments •Carry out serial dilution on high concentration samples and concentration determination •Using different test methods, such as ICP and X-ray fluorescence, and instruments for analytical measurements •Acquiring data, checking data quality and summarizing data for interpretation •Repair, trouble-shooting and perform routine and non-routine maintenance of the instruments independently •Well organize and file records of all analytical data and QC using Microsoft Excel and Microsoft Word

•Prepare reagents to synthesize DNA on the AB 3900 Synthesizer. •Operate lab equipment associated with the production and qualification of oligonucleotides. •Construct, purify, and test oligonucleotides. •Maintain instrument calibration, maintenance and validation. •Work in Cleavage and Deprotection Department to cleave the oligos in the columns form their supporting beads and deprotect. •Solid Phase Extraction (SPE) to separate free dye from the oligoa and dry down using Genevac. •Perform computer operations of data entry. •Perform thorough and accurate complete documentation. •Participate in team meeting. •Adhere to ISO 9000 guidelines and follow written SOP