Fiona H.

· Created PMO, generated PMO templates to track project progress, led risk assessment and mitigation implementation on quality related change controls, and conducted manufacturing campaign lesson learns for continuous improvement. · Spearheaded portfolio management on departmental programs according to corporate business needs strategically, and allocated resources for projects with successful decision making. · Contributed to departmental budget, reviewed request for proposal, and influenced leadership in department growth plan. · Introduced Agile Methodology into project management including creation of daily standup meetings between stakeholders to ensure any potential issues can be sorted out promptly. · Steered cross-functional team to work with an international client seeking path forward when one of GMP manufacturing batches failed product specification, provided impact assessment and recommendation after proactive discussions with both teams and moved project ahead with customer accepting the batch release as is. · Mentored 4 project managers to lead global Oligonucleotide Therapeutics & Diagnostics projects globally and secured good product quality as well as customer satisfaction.

· Directed 10 Oligonucleotides programs simultaneously from Pre-clinical process development to PhII clinical production under tight timeline and delivered final drug substance on schedule and within budget. · Instructed effective communication between internal stakeholders and early phase external collaborators such as academic institutions, CROs and vendors which contributed to satisfactory project completion with high quality product delivery. · Worked with Finance department closely to verify revenue reconciliation of each project milestone and accurate departmental forecast. · Guided 1 Operation Excellence project covering Quality Assurance, Quality Control, Manufacturing, Supply Chain, and Finance departments using Six Sigma mechanism to reduce GMP production deviations up to 80%. · Supported a multi-disciplinary team including Business Development, Quality Assurance, Operation, R&D and Facility, to establish a new GMP grade pipeline and expand production scale on Diagnostics products.

· Administered 3 external projects in vaccine development from small scale formulation screening through Phase II Process Characterization, plus 1 commercialized drug product stability program by drafting project plans, generating Gantt Chart using MS Project, hosting client meetings and following up on action items to establish expected project progress. · Headed 3 US based inter-company projects on CMC drug substance development, developed project charter based on corporate business needs and defined pricing for each sub-study. · Led a team of 4 to ensure revenue Sarbanes-Oxley-Act compliance of 424 projects at Catalent with responsibility to create contracts, track projects progress and arrange shipping/delivery services of raw materials through ERP system JD Edwards.

· Directed 2 mAb development programs including process development and technical transfer from 2 L lab scale to 500 L engineering scale production. · Presented weekly project updates in client meetings and addressed urgent problems during daily experiments, e.g. sudden cell death or pH instability. · Facilitated closure of urgent deviations under GMP compliance through proactive interaction with internal departments and presented root causes using fishbone diagram technique. · Negotiated with venders to verify adequate material supply for upcoming batch productions according to material planning. · Accomplished CMC related analytical method development as subject matter expert, including bioassays such as qPCR, ELISA, Octet and TECAN platform, LC based methods such as HPLCs, and characterization methods such as glycan analysis, SDS-PAGE, CE-SDS, and iCE · Established new methods of trace element impurity analysis using Inductively Coupled Plasma Mass Spectrometry to expand departmental capability, explore new business potentiality for quality control in small/large molecule Pharmaceuticals, resulting in a first-author publication and findings presented at Peptalk International Conference

• Identified a €162K cost saving approach on annual energy consumption for Top 5 global consumer goods company • Supervised a team of 5 to perform Bench-Marking analysis on factory energy consumption data by category/cluster and targeted on 34 worst in class factories • Interviewed 8 Cluster leaders of problematic factories and concluded on root causes • Developed a business strategy with € 248.71M total savings to tackle energy consumption problem across all factories, and helped client formalize the action plan to improve underperformed sites

• Conducted Industrial analysis on Market Sizing/Segmentation and Financials (Project NPV, Risk Profile, Monte Carlo Simulation and Sensitivity Analysis) for Client’s target product market • Advised company executives with best business model strategy to earn national grants of $2.9 M and get prepared for a better chance of M&A with big Pharmaceuticals

· Performed biochemistry analysis to explore Centrobin’s function on the induction of liver steatosis in MEF cell line and mouse model. · Designed analytical experiments of Immunoprecipitation, Immunohistochemistry, SDS-PAGE, Gel-Staining and Western-Blot to find the best way to measure Centrobin effect · Analyzed data quantitatively through Mass Spec and discovered innovative relationship between mitochondria dysfunction and liver metabolism disorder

• Coordinated between inter-department colleagues and external customers through Chinese liquor expeditions, seeking for product improvement and market share expansion

• Organized and analyzed drug adverse reaction data of National Hospital patients in Autoimmune Disorders and Type II Diabetes diseases • Recognized by upper management from optimization of data uploading system

• Quickly learned and managed all lab related Biochemistry experiments, such as Western Blot, DNA Cloning, Co-IP, IP, DNA/RNA extraction, and Real-Time PCR. • Screened the stable cell line of MLL-ELL in 293 cells, a kind of fusion gene combined with most part of H3K4 methyltransferase MLL1 and C terminal sequence of ELL, an RNA polymerase II elongation factor • Constructed Plasmid pCDNA5-FTF-SMYD5 through gene cloning, transfected it into HEK-293 cell, and detected the related expression with western blotting • Contributed in paper “Inhibition of cancer cell proliferation by 5-fluoro-2’-deoxycytidine, a DNA methylation inhibitor, through activation of DNA damage response pathway.” o Performed related experiments of cell toxicity measurement • Finished graduation thesis “The Analysis of functions of proteins interact with Histone Methyltransferase Subunit ASH2L” through Yeast Two Hybrid o found three novel proteins desired o Built three fusion plasmids particularly and performed transfection into 293-T human cells to measure the expression of target DNA

• Led a group of 10 to prepare course materials for Plant Physiology Laboratory class • Assisted instructor for experiment execution, with prior-course experiment designs and on-site instructions for trouble shooting • Graded 25 course assignments & lab reports