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

Job summary

This role involves leading the Manufacturing Science & Technology (MSAT) function within a biopharmaceutical organization, focusing on the development and manufacturing of antibody therapeutics. The Vice President will ensure robust manufacturing processes, oversee technology transfers, and manage lifecycle optimization of drug products.

Qualifications

• Advanced degree in Chemical Engineering, Biotechnology, or a related field.
• Over 15 years of experience in biopharmaceutical development and manufacturing, particularly in MSAT and process development.
• Strong expertise in technology transfer, scale-up, and process validation.
• In-depth knowledge of biologics manufacturing and GMP requirements, especially 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 development and manufacturing operations.
• Serve as the authority on process performance and robustness.
• 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 supply continuity.
• Build and lead high-performing MSAT 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 is preferred.

Education

• Advanced degree in a relevant field is required.

Tools

• Familiarity with regulatory compliance tools and manufacturing technologies in the biopharmaceutical sector.