Job Summary

• This position will influence life-cycle management of our company’s commercial products and include a specific focus on support of local testing requirements for our company's large molecule commercial products in China.
• The position will involve direct contact with government laboratories and functions in China (for example CDE and NIFDC) in addition to Contract Manufacturing and Contract Testing Organizations.
• Influence development of new chapters/sections of regulatory compendia or updates to existing compendial chapters/sections including, but not limited to, those in the Chinese Pharmacopoeia.

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Skills & Requirements

Key Requirements

• Bachelor’s Degree (BA/BS) with 12 years of relevant industry knowledge
• Master’s Degree (MA/MS) with 8 years of relevant industry knowledge
• PhD with 4 years of relevant industry knowledge
• Experience in biopharmaceutical manufacturing industry
• Ability to analyze, interpret, and troubleshoot analytical data
• Strong scientific, technical leadership, and troubleshooting skills
• Familiarity with regulatory-CMC topics and regulatory compendia
• Strong organizational and project management skills
• Strong oral and written communication skills

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