Analytical testing development, transfer, and validation
Biopharmaceutical manufacturing industry experience
Analyze, interpret, and troubleshoot analytical data
This position will influence life-cycle management of our company’s commercial products with a specific focus on support of local testing requirements in China
Job Summary
This position will influence life-cycle management of our company’s commercial products with a specific focus on support of local testing requirements in China.
Responsibilities include establishing and maintaining professional relationships with scientists in China's government and contract testing laboratories, supporting test method establishment, and facilitating logistics.
The role involves leading and participating on global cross-functional teams to facilitate rapid licensure and approval of commercial product extensions and influencing the development of regulatory compendia.
Matching Summary
This position will influence life-cycle management of our company’s commercial products with a specific focus on support of local testing requirements in China.
Skills & Requirements
Must-have
Analytical testing development, transfer, and validation
Biopharmaceutical manufacturing industry experience
Analyze, interpret, and troubleshoot analytical data
Scientific and technical leadership skills
Regulatory-CMC topics and compendia knowledge
Organizational and project management skills
Strong oral and written communication skills
Nice-to-have
Large molecule method development, validation, and transfer
Deviation management and change control processes
Laboratory data management systems experience
Software automation/digital systems experience
Cross-cultural competence
Key Requirements
Bachelor’s Degree with 12 years of relevant industry knowledge OR Master’s Degree with 8 years of relevant industry knowledge OR PhD with 4 years of relevant industry knowledge
Experience in biopharmaceutical manufacturing industry
Demonstrated strong scientific, technical leadership, and troubleshooting skills
Familiarity with regulatory-CMC topics and regulatory compendia
Strong organizational and project management skills