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Job #03353

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 Director of Analytical Services Anywhere USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Set up and manage the analytical services (chemistry and microbiology) for the companies manufacturing facilities in Suzhou (Solid Dose) and Ningbo (API) 2) Create and maintain SOP’s systems to comply with US FDA requirements. 3) Manage the internal and external analytical development programs. 4) Develop, validate and transfer analytical methods for the company in compliance with US FDA regulations. 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 supervisor. Requirements 1) Working Knowledge of US FDA standards 2) US ANDA and DMF requirements as related to lab methods operations and data handling and reporting 3) Lab management 4) Method development validation and transfer for US marketed of generic oral solid dosage forms 5) Organization and operation of pharmaceutical R$D and QC laboratories including control and scheduling of workloads, budgets and employee training and development 6) Working knowledge of analytical instrument qualification in USA 7) Working knowledge and ability to manage microbiological laboratories 8) Management skills 9) PH.D. 10) Experience in analytical development and QC of generic oral solid dosage forms and API within a US pharmaceutical manufacturing company. 11) 10 plus years industry experience 12) Chinese (Mandarin) a plus