Manager, Quality Control Chemistry

Responsibilities

• Lead the daily workflow of the QC Chemistry (CE) laboratory to support GMP manufacturing and testing
• Manage routine laboratory operations including validation, SOPs, specifications, and personnel training
• Ensure timely completion of in-process control, DS release, DP release, and stability testing
• Review laboratory test results to ensure strict adherence to Good Documentation Practices
• Oversee investigations of OOS events, discrepancies, lab errors, and equipment failures
• Implement effective corrective and preventive actions (CAPAs)
• Manage, motivate, coach, and mentor direct reports
• Ensure compliance with EHS standards and regulatory requirements (FDA/EU)
• Participate in internal and external GMP audits

Requirements

• Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, or a related scientific discipline
• 5+ years of GMP testing experience using capillary electrophoresis techniques in a regulated biotechnology or pharmaceutical environment
• 2+ years of managerial experience directly managing people
• Hands-on experience with capillary electrophoretic analytical methods such as CGE, CZE, and cIEF/icIEF
• Strong knowledge of USP/EP and cGMP/EU GMP regulations
• Proven leadership skills and experience managing teams or projects
• Excellent analytical, problem-solving, and communication skills

Preferred Qualifications

• Master's degree with 4+ years of relative experience
• Experience with instrument and equipment validation

About the Company

BeOne 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, BeOne is committed to radically improving access to medicines through a diverse pipeline of novel therapeutics.