Director of Manufacturing

Overview

Title: Director of Manufacturing Science & Technology

Location: Midwest US - Onsite - relocation support is provided!

Context: Biologics DS & DP CDMO

About the job

*** Candidates need to be based within the US for consideration***

• Develop annual plans for MST-related work, supervise implementation, and ensure alignment with company strategy.
• Lead the MST team to provide technical support to production, ensuring smooth and compliant execution of production activities.
• Guide and supervise the development of production-related process technologies to improve process capability, efficiency, and compliance.
• Resolve technical problems encountered in production and ensure stable process operation.
• Promote technology transfer and scale-up, ensuring process reproducibility and robustness.
• Support audits and inspections, ensuring the process and related documentation comply with GMP and regulatory requirements.
• Establish and optimize laboratory systems, procedures, and quality standards to ensure accuracy, reliability, and compliance of experimental data.
• Provide leadership, training, and professional development for the MST team to continuously improve their technical ability and overall performance.

• Master’s degree or above in biotechnology, pharmaceuticals, chemical engineering, or a related field.
• At least 10 years of relevant work experience in the biopharmaceutical industry, including more than 5 years of team management experience.
• Proficient knowledge in large molecule drug development, technology transfer, process optimization, and GMP compliance.
• Excellent problem-solving skills, communication, and teamwork spirit.
• Strong leadership and talent development capabilities.
• Proficient English skills (written and spoken).

• Experience with CDMO operations is preferred.
• Familiar with U.S. FDA and EU regulatory requirements.