zhanqian yu

Dr. Zhanqian Yu manages cGMP projects effectively to deliver quality API for clinical trials (Phase I to III) and has solid records of success in organic synthesis. He has authored 28 peer-reviewed papers in journals like Angew. Chem. Int. Ed. Engl., J. Med. Chem., and Chem. Eur. J. Etc. He is exceptionally good at scale-up and technology transfer from gram-scale reactions to good laboratory practice (GLP) synthesis (kilo-gram), to multi-kilogram scale reactions in cGMP manufacturing, and then to metric ton scale commercial production. Qualifications • Identifying workplace hazards for zero incident culture--lab safety inspections, monthly safety training, laboratory experiment safety evaluations, process hazard assessments, Safety Data Sheets, and knowledge of OSHA regulations. • An ability to work independently, to coach others, and to be a good team player--managing a team (up to 8 chemists), presenting technical data to customers, analytic team of chemists, and engineers to successfully deliver multi-kilo grams of Active Pharmaceutical Ingredients (APIs) on time • Technology transfer from milligram-scale reactions to good laboratory practice (GLP) synthesis (a kilogram scale), to multi-kilo-gram scale reactions in cGMP production, and then to metric ton scale reactions in commercial cGMP production • Good communication, organizational, and presentation skills • Extensive knowledge of synthetic chemistry, methodology development, process optimization, and scale-up of processes to the kilo-lab or pilot plant setting • An ability to design and develop high quality chemical processes for drug substance • Expertise in multi-step synthesis of complex organic molecules, including deuterated compounds and C13 labeled drugs • Familiarity with analytical techniques: HPLC, TLC, LC-MS, GC, IR, TGA, XRPD, NMR, KF, etc • Experience in Current Good Manufacturing Practices (cGMP)--producing master batch records, campaign summary, specifications, work instructions, process validation protocols and reports, risk assessment, documents for drug master file (DMF), and other aspects of QA documentation and compliance • Knowledge of ICH and FDA guidelines for Active Pharmaceutical Ingredients