MSAT Manager Product Leadership

MSAT Manager - Product Leadership

Are you a seasoned biopharmaceutical professional with a passion for product lifecycle strategy and regulatory excellence? A leading organization in the life sciences sector is seeking a Product Lifecycle Manager to oversee the end-to-end technical and regulatory stewardship of commercial biologic assets.

In this pivotal role, you'll serve as the primary technical authority for assigned products, guiding regulatory submissions, driving process improvements, and ensuring compliance with global standards. You'll collaborate across functions to shape and execute CMC strategies that support global market access and long-term product sustainability.

Key Responsibilities

• Lead the development and maintenance of robust control strategies for commercial biologics.
• Author and manage complex CMC documentation for global regulatory submissions.
• Identify and implement yield and process optimization initiatives in collaboration with technical teams.
• Monitor and analyze process performance data, contributing to Continued Process Verification (CPV) efforts.
• Prepare and review annual product quality reports and CPV documentation.
• Actively contribute to cross-site technical forums and knowledge-sharing initiatives.

Qualifications

• Bachelor's or Master's degree in a scientific discipline with 10+ years of experience in biopharmaceutical development, manufacturing sciences, or regulatory affairs.
• Strong command of global regulatory expectations (FDA, EMA, ICH) and validation practices for biologics.
• Proven expertise in CMC technical writing and regulatory submission strategy.
• Demonstrated ability to lead cross-functional initiatives in a matrixed environment.
• In-depth understanding of upstream and downstream bioprocessing principles.