QC Biochemical Manager

Responsibilities

• Manage and lead the biochemical quality control department to ensure GMP compliance with domestic and international regulatory requirements
• Establish antibody drug QC platforms and documentation systems, including SOPs, raw data templates, and instrument qualification (4Q)
• Lead the team in establishing biochemical QC analytical methods and building a method platform based on various pharmacopoeias
• Oversee method validation for non-pharmacopoeia methods transferred from the development department
• Implement and execute QC data integrity management to ensure traceability and authenticity in accordance with cGMP requirements
• Manage departmental development planning, budgeting, financial control, and organizational structure
• Drive team building through recruitment, training, performance evaluation, and culture development
• Participate in the establishment of the quality department's supplier management system

Requirements

• Bachelor's degree or above in Biochemistry, Bioanalysis, Analytical Chemistry, or a related field
• 7+ years of experience in a GMP biopharmaceutical environment
• 3+ years of management experience
• Extensive experience in pharmaceutical analysis and quality control, specifically in cell biological activity method development or testing
• Proficiency in English (listening, speaking, reading, and writing)
• Deep knowledge of international and domestic regulations, including ICH, NMPA, FDA, EMA, USP, ChP, and EP
• Strong understanding of biological drug QC instrumentation, method development, and validation
• Excellent leadership, project management, and communication skills

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients. We are dedicated to advancing precision medicine through innovative approaches in immunology and infectious diseases.