Downstream Production Manager

Responsibilities

• Manage and ensure downstream production processes are executed according to company requirements and GMP standards.
• Lead the drafting, revision, and auditing of GMP-related documentation for the downstream department.
• Optimize production processes and workflows, providing regular summaries and reports to management.
• Oversee technical training and assessments for production personnel regarding equipment, specifications, and processes.
• Coordinate change controls, risk assessments, and the implementation of corrective and preventive actions (CAPA).
• Investigate deviations, non-conformances, and abnormal events within the downstream production area.
• Participate in audits from regulatory bodies such as NMPA and FDA, and execute necessary rectification plans.
• Collaborate with R&D, MSAT, Supply Chain, Engineering, QA, and QC departments to ensure smooth production operations.

Requirements

• Bachelor's degree or higher in Biopharmaceuticals, Bioengineering, Biotechnology, or a related field.
• Minimum of 10 years of experience for Bachelor's degree holders, or 8 years for Master's degree holders.
• Proven experience in protein drug downstream process scale-up or commercial GMP manufacturing.
• Strong leadership experience in team management, including recruitment, training, and on-site management.
• Deep understanding of downstream production equipment operation, maintenance, and management.
• Thorough knowledge of GMP regulations and quality control processes (deviations, CAPA, etc.).
• Proficiency in English (CET-6 or equivalent) with the ability to read and write technical GMP documentation.
• Experience with domestic or international regulatory audits.

About the Company

BioNTech is a leading biotechnology company pioneering next-generation therapies for patients. We focus on developing innovative medicines, including mRNA-based therapeutics, to fight cancer and other serious diseases.