Associate Director, Drug Substance Manufacturing

Responsibilities

• Lead the technical implementation of large molecule manufacturing, including liquid aseptic filling and lyophilization
• Build and lead a highly skilled, focused, and well-trained manufacturing organization
• Manage equipment FAT/SAT/IOQ and commissioning processes while maintaining established timelines
• Define operational strategy and direction as a member of the site leadership team
• Ensure strict adherence to all quality and EHS compliance requirements
• Lead product changeover activities and provide scientific guidance for manufacturing facility design and validation
• Oversee technical reports, change controls, CAPA, and deviations

Requirements

• Bachelor's degree in Biotech, Biology, Chemical Engineering, Biochemistry, or Life Sciences
• Minimum of 8 years of experience in large molecule manufacturing with a focus on Cell Culture processing
• Minimum of 6 years in a leadership role
• Proven experience with single-use manufacturing processes
• Deep understanding of cGMP environments and FDA/EMA regulations
• Experience with successful regulatory inspections (e.g., PAI)
• Lean Six Sigma or Operational Excellence background with a track record of continuous improvement
• Proficiency with computer-based systems such as SCADA, DCS, and SAP

Preferred Qualifications

• Advanced degree (Master's or PhD)

Benefits

• Competitive salary range
• Annual bonus plan eligibility
• Discretionary equity awards and participation in Employee Stock Purchase Plan
• Comprehensive medical, dental, and vision insurance
• 401(k), FSA/HSA, and life insurance
• Paid Time Off and wellness programs

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 our diverse pipeline of novel therapeutics.