Jack Aurora | Chief Scientific Officer & R&D Director Generic Drugs
Hisun Pharmaceuticals

Dr. Jack Aurora is Ph.D. in pharmaceutical sciences with over 19 years of Quality and Compliance driven research and management experience to his credit. Dr. Aurora’s research experience is in all the dosage forms including but not limiting to solids, semi-solids, liquids and sterile with special emphasis for Novel Drug Delivery Systems including Controlled-Release and Nasal development and mfg. operations. At present Dr. Aurora is working in the capacity of Chief Scientific Officer, Generic Drugs for Hisun Pharma Co., Ltd. based in China. In this role Dr. Aurora is responsible for the set-up and implementation of the newly constructed facility for US FDA and EU submission, approval and commercialization aspects of generic drug development. His key areas of focus include strengthening (introducing Quality by Design (QbD) approach and culture of the development capabilities for ANDA products leading to the highest standard for global R&D and Corporate Quality Compliance for satisfactory approval from the regulatory agencies in US and Europe. Prior to this he has worked as VP Formulations Operations with Azopharma Product Development Group, and with Perrigo Company, Pharmascience, Labopharm, Patheon and Ranbaxy (from where he started his professional career) in various management and technical capacities. During all of his present and past assignments the development, implementation and maintenance of strong quality culture and regulatory compliance was a key focus and driver for growth. Dr. Aurora is also a consultant with GLG Healthcare and Biomedical Council and Guidepoint Global, associations of leading physicians, scientists, and other healthcare professionals. He is also acting as adjacent faculty member and Prestige Appointment with School of Pharmacy; University of Toledo, Seneca College and Toronto Institute of Pharmaceutical Technology (TIPT) based in Toronto. Dr. Aurora is also member of visiting scientist program sponsored by AAPS. Dr. Aurora is also editorial advisory board member of various scientific publications such as Drug Delivery Technology, Contract Pharma and Business Briefing scientific and business focused publications from US and Europe. Dr. Aurora research focuses and wealth of experience include development of Controlled-Release Systems, Pelletization Technology, and NDA 505(b)(2) and ANDA developmental and regulatory approval pathways. In the field of controlled-release development, he has 3 US and EU patents to his credit and another four are in process. During his last 2 assignments Dr. Aurora has successfully developed more than 7 NDA 505 (b)(2) and more than 50 ANDA. Recently, he was invited by AAPS for a round table speaker on “First to file Generics Opportunities” during the annual meeting in Atlanta. Dr. Aurora also has an extensive experience of design and implementation of new development lab and GMP pilot plant facilities. He has also successfully managed global research teams operating from different parts of world (with different work culture and practices) under one umbrella for cost and efficiencies management.