Huahua Jian

Lead a team to plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines. Originate novel approaches to solve experimental problems. Make pivotal contributions to drug product development strategy at project team level. Design experiments to generate analytical data to contribute to technical feasibility reports for strategic planning and evaluating commercial value of project proposals. Manage a group to conduct analytical development activities to support all stages of drug development including drug substance and drug product developments. Supervise and coordinate activities at contract labs (for drug substance, formulation, and analytical), and ensure quality of work. Author and review relevant sections of regulatory filings and prepare responses to CMC questions from regulatory agencies. Review and approve analytical data, technical reports and analytical methods in support of regulatory CMC filings. Identify, evaluate, recommend, and purchase new equipment to meet project needs. Collaborate with cross-functional groups to meet drug development milestones. Lead CMC Teams as required. Lead and/or contribute in various departmental and cross-functional teams. Keep current in analytical research including literature and technology advancement. Investigate new technology and research opportunities. Publish and give presentations at both internal and external meetings. Mentor and coach staff members for their career development. Lead department and lab management strategies and activities.

1. Planed analytical development strategies and activities. Manage CMC timelines and solve experimental problems. 2. Supported various CMC (Chemistry, Manufacturing, and Controls) activities in pharmaceutical development. 3. Wrote technical reports to support regulatory filings. Author and review relevant sections in regulatory submissions (IND, NDA). Prepare responses to CMC related regulatory questions. 3. Designed, managed and conducted analytical development activities to support all stages of drug development including drug substance and drug product. Provided analytical support to technical feasibility reports for strategic planning and evaluating commercial value of project proposals. 4. Supervised and coordinated activities at contract labs.

1. Developed and validated analytical methods for drug products and drug substances. Chromatographic methods: HPLC with various detection technique (ELSD, RI, Fluorescence, PDA, UV and MS). GC (including headspace). Spectroscopic methods (NMR, Mass Spectrometry, UV spectrophotometry).. 2. Characterized chemical and physical properties of new chemical entities and polymeric novel excipients. Develop methods and specifications to support regulatory filings. 3. Physicochemical characterization of therapeutic proteins (mAb, scFv, ADCs and PEGylated proteins). Chromatographic methods development and validation, including IEX, SEC and reverse phase. 4. Applied Quality by Desgin (QbD) and Design of Experiments (DoE) concepts to analytical method development and validation. 5. Wrote technical reports to support regulatory filings. contributed to relevant sections in regulatory submissions (IND, IMPD, NDA). 4. Supported various CMC (Chemistry, Manufacturing, and Controls) activities in pharmaceutical development. E.g. extractable/leachable studies, partition coefficient studies, and cleaning validation. Provided analytical chemistry support to pre-clinical, toxicology and clinical studies.

1. Developed LCMS and LCMSMS analytical methods for qualitative and quantitative applications. The analytes included a wide range of compounds, including: drug metabolites, compounds of forensic interest, hormones, environmental contaminants, stable isotope-labelled compounds, etc. 2. Isolated and purified drug impurities and metabolites from complex mixtures. Characterized these compounds by mass spectrometry and NMR for structural elucidation. 3. Developed and validated Quantitative NMR assay methods for Certified Reference Materials (CRM).

1. Synthesized drug metabolites or impurities to be used as analytical reference standards. Designed and executed multi-step synthesis. The synthesis target included a wide variety of compounds, including: metabolites of clinical and forensic interests; natural product semi-synthesis; product of environmental interests, stable isotope-labelled compounds, etc. 2. Developed synthesis processes for API manufacturing. Developed and validated synthesis processes for GMP materials.