Head of QC Separation

Outstanding local biopharma

Your new company

Your new role

• Lead a group of scientific staff performing separation testing, including HPLC, SDS-PAGE, CE, iCIEF, and PCR, 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 separation 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., MS, or BS in chemistry, biology or related field.

• Knowledge of separation testing in support of biopharmaceutical manufacturing is preferred.

• Fluent in English and Chinese

• Be familiar with requirements of ICH, FDA, and NMPA regulations



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. #1232682

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Shanghai
Specialism
Life Sciences
Ref:
1232682

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

Similar jobs to Head of QC Separation

  • External Senior Quality Manager-API

    Outstanding global MNC
    Shanghai
  • QA Manager

    QA Manager
    Shanghai
  • QA Manager/Sr

    QA
    Shanghai
  • Quality Process Manager

    Global leading shipping company is looking for a process manager.
    Shanghai
  • Assistant QA Manager for R&D

    Outstanding global MNC
    Shanghai