宜兴招聘

Requirements:
？ Master’s Degree in Life Sciences is required, PhD preferred and MBA is a plus.
？ 10+ years of relevant experience is required.
？ Previous industry and Business Development experience is required.
？ Knowledge of GMP/GLP and global regulatory requirements is required.
？ Previous experience managing personnel and projects is required.
？ Must be experienced with leading technical/operations management to provide testing for biologics that will be utilized in human health technologies from pre-clinical trial phases through to commercial products.
？ Must be fluent in oral and written Mandarin Chinese and English.
？ Technical knowledge should include detection capabilities for virology, molecular and cellular biology, and /or general knowledge of viral clearance or other biosafety testing technologies.
？ Needs a solid understanding of biologics regulations, including GLP and GMP requirements, as well as experience or capability for dealing with government regulatory agencies such as the Chinese FDA (SFDA), US-FDA, the EMA, and the Korean FDA.

Job Descriptions:
？ Responsible for managing a new biologics testing facility in Suzhou, China that will come on line in 2013.
？ Responsible for oversight of standard testing laboratories for evaluating cell lines used to produce biologics or viral vaccines, cell therapeutics, and tests for releasing product lots of various biologics as well as oversee validation studies for process validations such as viral and / or mycoplasma clearances.
？ Responsible for over-seeing and the overall Building Operations, Quality Assurance, Human Resources, Finance, Sales/Marketing, Purchasing, Shipping, Facilities and Logistics.
？ Revenue and Profit: Implementing financial and technical controls.
？ Business development and sales and marketing to Chinese customers.
？ Successful external alliances (government/regulatory).
？ Coordination with Technical leader to plan and develop :Project plans and product menu; Oversight and guidance of testing services; Strategic planning for growth, capacity and services.
？ Key site metrics.
？ Quality Assurance and Quality compliance.
？ Regulatory compliance.
？ Facility management.
？ Global interaction with other sites.
？ Leadership, development and management of staff.

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