Associate Director/Director, Analytical

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