Head of QC Microbial Testing

Outstanding local biopharma

Your new company

Your new role

Lead a group of scientific staff performing microbial testing, including bioburden testing, endotoxin testing and sterility testing, to support biopharmaceutical product manufacturing and release;

• Lead investigations in response to OOS, OOL, contamination investigations, and adverse trends;

• Provide Quality Control review and approval of Policies, Operational Standards, SOPs, validation protocols and reports;

• Work collaboratively across organization and sites for microbiological related verification/validation/investigation to meet organizational goals;

• Be responsible for direct supervision of scientific staff, and strong collaboration with partner organizations;

• Draft and review regulatory submissions including INDs and BLAs;

• Develop young staff, inspire innovation and operational excellence and foster a continuous learning environment;

• Communicate ideas, project goals and results to cross-functional team members;

• Guarantee GMP compliance and data integrity;

• Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.

What you'll need to succeed

• Ph.D. with 2+ years, M.S. with 5+ years, BS with 8+ years of experiences in biopharmaceutical industry is preferred.

• Experience with analytical method testing or development in biological macromolecules (biologics) is preferred.

• Hands-on experiences in microbial testing are required.

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1232683


Job Type
Life Sciences

Talk to a consultant

Talk to Gioia Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: 02123229656

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