Vice President, Manufacturing Science & Technology (Biopharmaceutical, Remote)

Job summary

The role involves leading the Manufacturing Science & Technology (MSAT) function within a biopharmaceutical organization, focusing on ensuring robust manufacturing processes and technology transfers for antibody therapeutics.

Qualifications

• Advanced degree in Chemical Engineering, Biotechnology, or a related field
• Over 15 years of experience in biopharmaceutical development and manufacturing, specifically in MSAT and process development
• Strong expertise in technology transfer, scale-up, and process validation
• In-depth knowledge of biologics manufacturing and GMP requirements, particularly with antibody-based drugs
• Experience with global GMP regulations and lifecycle management (FDA, EMA, ICH)
• Proven leadership and collaboration skills

Responsibilities

• Lead the MSAT function, providing oversight across internal development and external manufacturing operations
• Serve as the primary authority on process performance, scale-up, and continued process verification
• Troubleshoot and resolve complex manufacturing challenges
• Standardize technology transfer strategies throughout the development lifecycle
• Ensure successful scale-up activities while maintaining product quality
• Author and review key CMC sections of global regulatory filings
• Collaborate with cross-functional teams to ensure compliance and uninterrupted supply
• Build and lead high-performing teams focused on scientific rigor and continuous improvement

Skills

• Strong analytical and problem-solving capabilities
• Ability to operate effectively in a fast-paced, growth-oriented environment
• Experience with both internal manufacturing and CMO/CDMO oversight preferred

Education

• Advanced degree in a relevant scientific discipline required

Tools

• Familiarity with regulatory compliance tools and manufacturing technologies relevant to biopharmaceuticals