Key Responsibilities:

1. Make high-level technical and management decisions and determine priorities for GMP production activities with different clinical and commercial production needs.

2. Lead and coordinate the cross-functional teams within the manufacturing organization to conduct efficient, client-oriented flexible production campaigns to ensure timely delivery of quality products.

3. Ensure CGMP compliant status for personnel, materials, process, equipment and facilities throughout each production run.

4. Coordinate with Process Development and Quality Units to ensure smooth and efficient technology transfer and timely IND enabling GMP runs or BLA enabling PPQ (Process Performance Qualification) runs.

5. Ensure efficient communications with domestic and global clients and RA (Regulatory Affairs) to assist successful IND filings to global health agencies, including NMPA, FDA, EMA, ANNVISA, etc.

6. Implement Lean Manufacturing practice to improve operation efficiency and reduce product cost.

Qualifications:

1. Master's or PhD degree in pharmacy, bioengineering, or biotechnology-related majors. MBA degree is a plus.

2. Fluent oral and written Chinese and English communication skills.

3. A minimum of 8 years production management experience in a US, European or global MNC biopharmaceutical production setting.

4. Broad and solid knowledge of drug development lifecycle across multiple areas, including CMC Development, Process Validation, GMP manufacturing, Supply Chain and Global Regulatory filings.

5. Hands-on experience with commercial-stage biologics, particularly with manufacturing using 500L-2000L bioreactors in pharmaceutical companies or CDMOs.

6. Exceptional leadership skills, including positive inspiration to subordinates and peers, strong business ownership, organizational awareness, lean manufacturing, influencing/negotiation and conflict resolution skills, goal-oriented decision-making and teamwork promoting abilities.