Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Lead Quality Control Organization including Biochemistry, Physicochemistry, Microbiology and Environmental Monitoring, and Stability groups to perform in-process, lot release and stability testing for early and late stage programs.
  • Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation and promote collaboration with partner organizations.
  • Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Strong knowledge of GMPs and quality systems with experience managing deviation, change control, and CAPA. Assist regulatory audit and inspections.
  • Lead quality control system improvement initiatives. Projects may include writing and reviewing QC SOPs, designing and implementing systems (LIMS, E-notebook etc.).
  • Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs.
  • Develop talent, inspire innovation and operational excellence and foster a continuous learning and improvement environment.
  • Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
  • Should be an effective communicator of ideas, project goals and results to cross-functional team members.

Basic Qualifications:

  • Requires a Ph.D. in analytical chemistry, biochemistry, or related life sciences degree and 12+ years of relevant experience that demonstrates an expertise in assay qualification/validation, release and stability testing and QC operations.
  • Extensive hands-on experience in biochemistry, HPLC/CE and QC operations in cGMP environment.
  • Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
  • Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
  • Experience interacting with clients and health authorities (CFDA, FDA, EMA etc.) preferred.

Primary Location: China – Shanghai

To apply please send your application to HR_Biologics@wuxiapptec.com

BACK