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Job #03352

About our client Our client is a new, venture capital-backed generic pharmaceutical company with a low-cost, vertically-integrated manufacturing platform in China and a sales and distribution organization in the U.S. They just completed the acquisition of an oral solid dose manufacturing facility in Suzhou China and an API manufacturing facility in Ningbo China. Due to this exciting growth in the company, they have retained Sterling Life Sciences to help them identify a seasoned VP of R&D to join their management team. Position Location Vice President of Research & Development China/USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and maintain product development and technical transfer systems for the company in compliance with US FDA regulations. 2) Create and maintain the product development and technical transfer SOP’s systems to comply with US FDA requirements. 3) Manage the internal and external development programs. 4) Oversee clinical programs required for inclusion in US ANDA submission. 5) Recruit and train staff to comply with US FDA Standards, reinforce training and motivate individuals. 6) Train & develop subordinates. 7) Other tasks assigned by superior. Requirements 1) Knowledge of US FDA standards 2) US ANDA 3) Project management 4) Product Development (API and Formulation) of generic oral solid dosage forms 5) Design of product development laboratories 6) Definition and management of clinical studies programs 7) Characterization and sourcing of API’s, raw materials and packaging components. 8) Method development transfer and validation 9) Equipment, process and cleaning validation 10) Familiarity with GLP, GMP and Good Clinical Practice Regulations 11) Management skills