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
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.
Matching 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.
Skills & Requirements
Must-have
Analytical testing development
Biopharmaceutical manufacturing industry
Troubleshoot analytical data
Global cross-functional teams
Chinese Pharmacopoeia
Regulatory compendia
Nice-to-have
Large molecule method development
Deviation management
Change control processes
Laboratory data management systems
Key Requirements
Bachelor’s Degree with 12 years of experience OR Master’s Degree with 8 years of experience OR PhD with 4 years of experience
Biopharmaceutical manufacturing industry experience
Strong scientific, technical leadership, and troubleshooting skills
Familiarity with regulatory-CMC topics
Strong organizational and project management skills