Xinglong Jiang
Senior Vice President
About
Over 26 years of experience in leading teams for drug research and development including DMPK, Tox and developing safe and robust manufacturing processes for drug substances and drug products in cGMP environments for different stages of drug development. Proven track record in chemical process development, scale-up, and technology transfer of small molecules. Broad knowledge and experience in regulatory requirements from different agencies including FDA, EMA, TGA, and NMPA. Excellent leadership and interpersonal skills. Published more than 35 patents and peer-reviewed scientific papers
United States
Hillsborough
Biotechnology
Organic Chemistry, CMC, LC-MS, HPLC, Chemistry, NMR, Analytical Chemistry, Drug Discovery, Drug Development, Chromatography, Pharmaceutical Industry, Medicinal Chemistry, Drug Delivery, Technology Transfer, Drug Design, Organic Synthesis, GMP, GLP, Clinical Development, Process Simulation
Experience

Senior Vice President
Structure Therapeutics Inc
Shanghai, China
• Lead Teams including CMC, Tox and DMPK for drug discovery and development • Collaborate efficiently with CROs for outsourcing strategies to accelerate project development • Align strategies with other line functions for discovery and clinical trials • Develop and execute the strategies to build a strong, talented team for preclinical development

Director
Shanghai City, China
Lead China CMC SM API team for Process R & D to deliver Janssen’s API project portfolio on time with high quality. Develop and execute the outsourcing strategies to build strong partnership with CROs. Collaborate effectively and efficiently with China CMC and global line functions and CROs as well to leverage synergy for increasing productivity

Head of CMC
AstraZeneca Innovation Center China
Shanghai, China
Oversee daily activities including API Development, Analytical Development, Drug Product Development and Clinical Supply Chain in small molecules at ICC. Lead, develop and execute the overall CMC strategy for R & D from preclinical development through to new drug approval in alignment with China R&D’s and global pharmaceutical development strategic plan. Interacting with CFDA closely regarding filing IND and NDA in China. Collaborate and partner with colleagues from the China R&D, Global Pharmaceutical Development, DMPK, Toxicology, Technical operations, Quality and Regulatory CMC to achieve team and company goals. Build and strengthen strategic partnerships with external parties in China in alignment with overall global pharmaceutical development sourcing strategy. Provide process chemistry ideas and solutions; Design, develop and optimize synthetic routes for the preparation of active pharmaceutical ingredients and their intermediates.

Fellow (2001 to 2005),Senior Fellow (2006 to 2012)
Novartis Pharmaceuticals Co.
East Hanover, NJ
Novartis Pharmaceuticals - East Hanover, NJ 2001 - Process R &D • Contributed significantly to projects for Process Research and Development at different development stages from Research to marketed products. Designed and executed new synthetic routes using Green Chemistry principles to shorten synthetic steps and reduce costs. • Developed safe and robust manufacturing processes for intermediates and GMP APIs in cGMP environments. Hands-on laboratory scale ranging from milligrams to kilograms. • Accumulated broad knowledge and hands-on experience in manufacturing of APIs and analytical method development. • Prepared documentations for CMC section of IND and NDA filings and worked closely with other line functions to ensure timely deliveries. • Promoted science and technology at global Chemical and Analytical Development (CHAD) as a representative from the US for Chemistry Network. • Communicated and coordinated with Drug Discovery Project Team Leaders for Ophthalmology programs as liaison from global CHAD to successfully transfer projects from Drug Discovery Group to CHAD for development. • Published eight patents and twenty-five peer-reviewed papers. Management & Project Management Experiences • Supervised scientists and demonstrated ability to develop, manage and drive a high performing technical development group to achieve beyond the original goals. • Trained and mentored three Summer Interns which resulted in accomplishments of several research projects. • Expedited to establish the Chemical Development and the Pilot Plant operations in China (International assignment to Novartis China, 2009). Initiated Lunch & Learn program to teach and train colleagues in China from the known manufacturing processes to increase productivity. • Led project teams as project leader (2004-2006) on multiple projects through all development stages. Developed contingency plans to ensure the completion of the projects on time.

Principal Scientist
Roche Carolina Inc.
Florence, South Carolina
Process Research & Development • Contributed to process development for projects including designing new synthetic routes, establishing Proven Acceptable Ranges [PARs] for Critical Process Parameters. Supported the Pilot Plant and Manufacture campaigns for an anti-obesity drug-Xenical and an anti-cancer drug Xeloda.

Postdoctoral associate
Research triangle Park, North Carolina
Supervisor: Dr. F. Ivy Carroll (Vice President, CSL of RTI) Drug Discovery and SAR Study in CNS • Designed and synthesized novel substituted-6-azabicyclo[3.2.1]octanes and tropane alkaloids as well as new diazabicyclic compounds for the treatment of drug addiction and other CNS diseases.
Xinglong Jiang's Contact Information
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