• Lead a group of QC managers and analysts to perform in-process, lot release and stability testing by HPLC/UPLC and CE based methods for protein therapeutics 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. Regulatory audit and inspection experience preferred.
• 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, HPLC/UPLC, CE and SOPs.
• Draft and review of relevant CMC sections for regulatory submissions including INDs and BLAs.
• The applicant should be an effective communicator of ideas, project goals and results to cross-functional team members.

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