Interactions with government laboratories in china
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
Global analytical technical oversight
Large molecule commercial products in China
Interactions with government laboratories in China
Establish and maintain professional relationships
Support establishment of test methods
Facilitate logistics activities
Lead global cross-functional teams
Influence development of regulatory compendia
Nice-to-have
Proactive and timely communication
Systematic and thoughtful manner
Positive, proactive, and service-oriented mindset
Key Requirements
Bachelor’s Degree with 12 years of relevant industry knowledge
Master’s Degree 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
Demonstrated scientific, technical leadership, and troubleshooting skills
Familiarity with regulatory-CMC topics and regulatory compendia
Strong organizational and project management skills