Fangfang (Flora) Chen

• Supporting 3 BLA and 5 CTA submissions, including mAb, bispecific antibody, enzyme and small molecules, achieved 1 global simultaneous BLA approval, 1 sBLA global simultaneous submission, 1 BLA submission for old product and 5 CTA approvals • Providing technical supports to CMC dossier related activities (e.g., dossier review and proofreading for M1, M2.3 and M3, HA interactions, responses to query, contract and registration testing) for China CTA and BLA submissions • Identify and provide CMC risk assessment to local and global teams • Participating in registration strategy discussion for CMC activities and updating China specific requirements to global team • Fully understand the plan, progress, and status of the pipeline development projects in China and reflect the information to global CMC Experts NBE and relevant functions • Contribute to interactions with Chinese regulatory agencies and institutions (e.g. CDE/NIFDC/Chinese Pharmacopeia/RDPAC), based on proactive work with BI China functions (primarily LRA), global development functions and industry consortia

• Lead an analytical team (8-10 FTE) to support physical-chemical analytical development and routine testing for process development, drug substances and drug products for multiple projects of IND, including mAb, bispecific antibody, nanobody, ADC and fusion protein • Specification setting for drug substances, drug products and placebos • Developed CMC analytical strategy and ensuring best practices in deliverables, including analytical methods, specification, characterization, stability study, comparability study, in-use study and relevant CMC dossiers (3.2.S.1, 3.2.S.3.1, 3.2.S.3.2, 3.2.S.4, 3.2.S.5, 3.2.S.7, 3.2.P.1, 3.2.P.2, 3.2.P.5, 3.2.P.6, 3.2.P.8) • Drafted responses to questions from HA and clients

• Drafted and reviewed of relevant CMC dossiers for regulatory submissions (3.2.S.1, 3.2.S.3.1, 3.2.S.3.2, 3.2.S.4, 3.2.S.5, 3.2.S.7, 3.2.P.1, 3.2.P.2, 3.2.P.5, 3.2.P.6, 3.2.P.8) • Performed technical review of study data, protocols and reports to ensure delivery of high quality of compliant results • Communicated ideas, project goals and results effectively to clients and cross-functional team members as analytical leader • Lead junior scientists to develop HPLC, CE-SDS, iCIEF methods for development of protein therapeutics for CMC applications from cell line development to clinical study, including method development, evaluation, transfer, qualification and trouble shooting • Characterization of therapeutic proteins including PTMs, glycosylation, sequence variants etc. • Oversaw delivery of analytical results by liaising with relevant analysts, including iCIEF, CE, Caliper, N-glycan mapping, SEC, Titer, Peptide Mapping, Deglycosylated Reduced Mass, Intact Mass, ELISA, Endotoxin, HCP, UV280, Color, Clarity, pH, Osmolality, Extractable volume, CCIT, Sterility and Bioburden etc. • Supported the process development, manufacturing, release testing, characterization, stability, in-use study, comparability study and process-related investigations in a timely manner

• Conducted a comprehensive survey of the fate of 71 perfluoroalkyl substance (PFASs) and total organic fluorine contamination in water, sludge, and biota in an environmental forensics lab • Preparation of technical and project summary reports for industry partners and government agencies • Communication of research findings at international conferences • Supervised student for PFAS analysis in human milk Skills: UPLC/ESI-MSMS (Waters Xevo-TQS, Waters Quattro Premier, Agilent 6490, ABsciex Qtrap 5500, API 4000 and Shimadzu 8030), UPC2-MSMS (SFC), Combustion Ion Chromatography (CIC)

• Principal Investigator (PI): Placental transfer of novel PFASs in matched maternal, cord serum and placenta, 2015-2017 • Assessed the occurrence and distribution of perfluoroalkyl substance (PFAS) isomers and novel PFAS alternatives in umbilical cord serum and placenta, as well as the transplacental transfer and neonatal exposure risks of these compounds • Supervised two Ph.D. students: independently designed their research projects, and monitored their progress • Experience as a reviewer for the Journal of Chromatography A Skills: Project management, public speaking, UPLC-MSMS

• Used QSAR and mass balance model to investigate the PK and bioaccumulation mechanisms of pharmaceuticals and other ionizable organic chemicals in fish • Developed analytical methods to quantify concentrations of 12 pharmaceuticals and 21 PFASs in water and fish tissues, e.g. muscle, liver, eggs and blood • Designed a flow-through chemical exposure system for ecotoxicological risk assessment for fish • Taught undergraduates in lab practical lessons (Environmental Microbiology) • Mentored four undergraduates and one junior Ph.D. student: taught them experimental skills, participated in their project designs and monitored their progress to meet deadlines

Conducted water quality analysis

Administrative support for general manager of public relations

• Achieved translation of more than ten operation manuals for water quality analytical instruments • Compiled technical parameters for instruments and updated in database

Thesis：Bioaccumulation, tissue distribution and maternal transfer of ionogenic organic contaminants in zebrafish (Danio rerio) Projects: Evaluated the toxicokinetics and bioconcentration factors (BCFs) of PPCPs and PFASs in zebrafish and assessed the role of key biological constituents (proteins, phospholipids and neutral lipids) and influence on the bioaccumulation behavior of these chemicals in zebrafish. Developed new analytical methods using UPLC-MSMS in collaboration with Agilent Technologies. Skills: UPLC-MSMS, solid phase extraction (SPE), accelerated solvent extraction (ASE), gel permeation chromatography (GPC), quality assurance and quality control (QA&QC), chemical exposure of fish embryos and adult fish, chemical exposure system design, modelling, technical writing, project design, field sampling, fish farming, fish dissecting, data analysis, OECD guideline

Thesis: Interactions of Reactive Brilliant Red X-3B with biomacromolecules Project: Investigated the interactions of reactive brilliant red X-3B (RBR) as a representative of anionic azo compounds with bovine serum albumin (BSA), lysozyme and human serum albumin (HSA) Skills: UV-Vis Spectroscopy, ICP-MS, Fluorescence spectroscopy (FL), HPLC-UV, HPLC-FL, isothermal titration calorimetry (ITC), circular dichroism spectroscopy (CD)

Thesis: Chromophore-decolorizing with free radical and application to photometric determination of copper with acid chrome dark blue Skills: AAS, Ion Chromatography (IC), FL, UV-Vis Spectroscopy