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Job #03596

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 completed the acquisition of an oral solid dose manufacturing facility in Suzhou China and an API manufacturing facility in Ningbo China last year. Due to this exciting growth in the company, they have engaged Sterling Life Sciences to help them identify a seasoned Director of API Development to join their management team. The successful candidate will be relocated from the US/Canada and be based in Ningbo, China. Position Location Director of API Development USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan, direct and execute the API research 2) Guide and mentor the development team (16) to develop small molecule generic APIs 3) Integrate this process into the overall generic drug development strategy of the company 4) Develop and implement a successful strategy to deliver 6 – 10 DMFs per year for FDA submission 5) Provide vision and guidance in preparing the overall R&D strategic plan 6) Create seamless partnerships with the other R&D heads and the heads of other core areas (Marketing, Sales, Finance, Production and Business Development) 7) Lead scientists to the highest level of scientific excellence and productivity in the creation of API synthetic processes 8) Manage, support and evaluate external strategic alliance partners 9) Seek partnerships to ensure maximum efficiencies and leading-edge scientific capabilities 10) Prioritize, allocate and focus resources to provide the most rapid, effective identification and development of API candidates 11) Identify and implement technologies to expedite the API process 12) Create and sustain a company culture with the highest ethical and scientific standards and teamwork to achieve R&D objectives Requirements 1) Ph. D. in Pharmaceutics, Organic Chemistry or a related field with minimum 10 years of API development experience in pharmaceuticals (5 of those years in managing employees) 2) MS in a similar discipline with 15 years of experience and 5 years in management 3) Experience in directing and managing the research activities to scheduled deadlines 4) Complete familiarity and knowledge of cGMP and GLP 5) Extensive understanding of the API development process as well as considerable 6) Demonstrated success in transferring R&D API processes into production 7) Demonstrated success in preparing and filing DMFs to the FDA 8) Individual with a proactive management style characterized by effective leadership, commitment, enthusiasm, communication and teamwork 9) Ability to collaborate successfully with both internal and external colleagues to achieve company objectives