Director, Drug Product Manufacturing

Responsibilities

• Lead a highly skilled manufacturing organization focused on large molecule drug product processes, including liquid aseptic filling and lyophilization
• Define operational strategy and direction as a member of the site leadership team
• Oversee equipment FAT/SAT/IOQ and commissioning processes while maintaining established timelines
• Ensure strict adherence to all quality and EHS compliance requirements
• Lead technical implementation, process optimizations, and technology transfers
• Provide scientific guidance and oversight regarding technical, regulatory, and intellectual property considerations
• Manage quality system requirements including technical reports, change controls, CAPA, and deviations
• Lead Product Change Over (PCO) activities and ensure GMP readiness

Requirements

• Bachelor’s degree in Biotech, Biology, Chemical Engineering, Biochemistry, or Life Sciences (Master’s or PhD preferred)
• Minimum of 10 years of experience in large molecule manufacturing with a focus on Drug Product processes
• Minimum of 7 years in a leadership role
• Deep expertise working in a cGMP environment
• Proven experience with FDA/EMA regulations and successful regulatory inspections (e.g., PAI)
• Strong background in Lean Six Sigma or operational excellence with a track record of continuous improvement
• Proficiency with computer-based systems such as SCADA, DCS, and SAP

About the Company

BeiGene is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a global team of over 11,000 colleagues, we are committed to radically improving access to medicines through a diverse pipeline of novel therapeutics.