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.
Lead and/or participate on global cross-functional teams and work effectively with multiple disciplines and personalities to facilitate rapid licensure and approval of commercial product extensions for our company’s biologics and vaccines.
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
large molecule commercial products
China government laboratories
technical discussions and troubleshooting
global cross-functional teams
regulatory compendia updates
Nice-to-have
proactive and timely communication
service-oriented mindset
cross-cultural competence
Key Requirements
Bachelor’s Degree with 12 years of industry knowledge
Master’s Degree with 8 years of industry knowledge
PhD with 4 years of 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