hongfei zhang

* Developed, modified, and optimized analytical methods for testing drug substances and drug products. * Developed and validated HPLC, UPLC and GC methods for quantification and characterization of actives and impurities according to cGMP regulatory guidelines. * Investigated and troubleshot analytical methodology problems. Coached other chemists for method transfer and sample analysis. * Researched, conducted, and evaluated stability information for drug substances and drug products by conducting stress studies during method optimization and validation. Use LC and GC instruments to separate and identify impurities and metabolites with different kinds of detectors. * Provided expert advice in support of development projects on critical pharmaceutical proprieties that impact formulation development issues such as compatibility and stability.

* Developed and executed a global project plan for a new product launch, resulting in a 35% increase in revenue. * Developed, modified, evaluated, and optimized analytical methods for testing drug substances and drug products. * Assisted in the development of the installation strategy for all quality control methods necessary for commercialization of pharmaceutical products. * Wrote the test methods, analytical reports, and SOPs. Designed protocols for method validation and conducted forced degradation studies. * Qualified and validated HPLC and GC methods for quantification and characterization of actives and impurities according to cGMP regulatory guidelines. * Investigated and troubleshot analytical methodology problems. Coached commercialized lab chemists for method transfer and sample analysis. * Led Pharmaceutical Development compound development, cross-functional project teams, overseeing project strategy and executions. * Had technical ownership of specific assigned technologies according to capability and interests.

* Developed and validated analytical and biochemical methods for pre-clinical and clinical trial drugs. * Assisted in the development of the installation strategy for all quality control methods necessary for in-process, finished products and stability samples. * Wrote analytical assay and related substance testing methods, analytical reports, and SOPs. Designed protocols for method validation or qualification and conducted forced degradation studies. * Managed stability programs including study design, protocol writing, review, and approval. Conducted stability on pilot scale batches and interpreted data to develop sound conclusions. * Worked effectively with the formulation scientist to design and execute process experiments. * Conducted laboratory investigations for OOS/aberrant testing results. * Provided accurate analytical results for stability and released samples in a timely manner.

Provided technical direction within the team for product development projects. * Planned and managed study site activities and provides ongoing updates of site status to management. * Designed and developed robust, scalable formulations, and conducts drug product process development and process optimization activities. * Designed and conducted experiments to evaluate pharmaceutical properties such as solubility, stability, safety (risk assessments) and crystallinity of small molecule drug candidates. * Performed compatibility and stability studies to propose and assess early formulation candidates. * Developed, optimized and implemented analytical methods for release and stability testing of drug substances (APIs) and drug products (small molecule and biological drugs). * Conducted independent development, validation, inspection, and evaluation of analytical methods. Implemented new analysis techniques. * Created, checked, and assessed documents (stability protocols and reports, method development protocols and reports, method validation protocols and reports, SOPs, laboratory qualification protocols and reports, etc.).

* Develop analytical method for small molecules and biologics drug, such as quantitation of oligonucleotide, protein, peptide, vaccine (anti-cancer products) to support the clinical research studies and product launch. * Design, evaluation and monitoring of stability programs for drug substances and drug products, post approved stability requirements and statistical analysis. * Develop research approaches to address complex research and measurement challenges. * Identify and develop new processes that create distinct value and enable business growth. * Provide expert technical input with respect to method validation requirements and related regulatory requirements. * Provide project updates, analysis, and advice to cross-functional teams, set deadlines, write SOPs for team efforts and ensure team accountability. * Develop and improve measurement and control systems to ensure highly effective performance in terms of productivity and quality. * Support the quality studies & control activities during manufacturing process and identify critical quality attributes through drug products. * Write, review, and approve SOPs, test methods, laboratory reports, laboratory logs/worksheets, work instructions, forms, deviations, OOS/OOT investigations, CAPA’s, change controls, and other relevant GMP records for compliance. Review laboratory test reports and quality control data. Support the Quality Assurance department by setting specification limits for pharmaceutical ingredients and finished products to ensure quality, safety, and efficacy. * Conduct regular quality audits to ensure compliance with industry standards. Inspect products and materials to identify defects and recommend corrective actions. * Develop impurities control strategies, including potentially mutagenic impurities and nitrosamine impurities. * Collaborate with QC Manager and subject matter experts to assess the most appropriate analytical approach to support project activities.

Develop analytical method for small molecules and biologics drug, such as quantitation of oligonucleotide, protein, peptide, vaccine (anti-cancer products) to support the clinical research studies and product launch. Design, evaluation and monitoring of stability programs for drug substances and drug products, post approved stability requirements and statistical analysis.