Associate Director/Director, Analytical

Jiangsu Province, Suzhou, Taizhou
Posted 3 years ago

Main Responsibilities:

  • Direct and manage analytical teams in all aspects of routine operations, including staff hiring and development, daily operation, GMP compliance, budget, and expense tracking
  • Oversee and coordinate analytical development at Ascentage Pharma and with external contractors for new drug development
  • Coordinate development of analytical and control tests for API, starting materials, process intermediates, and finished drug products at Ascentage Pharma and through CROs
  • Organize and conduct INDs and NDA filings, and Annual Reports
  • Handle audit/inspection by regulatory agency such as FDA, EMA, and CFDA
  • Be responsible for increasing the operation efficiency and productivity while improving the current quality systems and ensuring full compliance to all applicable regulatory standards within the Analytical Center

Minimum Requirements:

  • M.S. or Ph.D. in Analytical Chemistry or related field.
  • At least 10 years above working experience in Analytical field in Pharma Industry.
  • Familiar with requirements of the FDA, EMA and CFDA regulations, ICH guidelines


Pharmaceutical Development

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