MSAT Lifecycle Management Manager

MSAT Lifecycle Management Lead

Are you passionate about driving excellence in product lifecycle management within the biopharmaceutical industry? We are seeking a Lifecycle Management Lead to join a dynamic technical operations team supporting commercial biologics manufacturing.

In this pivotal role, you will shape and oversee lifecycle strategies for commercial-stage biologics, ensuring robust validation and continuous process verification (CPV) practices. You'll collaborate across global and site-based teams to uphold the highest standards of compliance, innovation, and operational performance.

Key Responsibilities

• Develop and maintain lifecycle and validation strategies for late-stage biologics.
• Lead CPV initiatives, including data review, trend analysis, and cross-functional meetings.
• Serve as the site subject matter expert for CPV and process validation during audits and inspections.
• Partner with automation and data science teams to enhance process monitoring and control.
• Review and approve CPV documentation, ensuring alignment with industry best practices and regulatory expectations.
• Contribute to global communities of practice and task forces focused on lifecycle excellence.

Qualifications

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• 10+ years of experience in biopharmaceutical process development, MSAT, or CMC roles.
• Deep expertise in process validation, CPV, and lifecycle management for biologics.
• Strong understanding of ICH guidelines, GMP principles, and regulatory trends.
• Proven ability to lead cross-functional initiatives and influence global stakeholders.
• Excellent communication, leadership, and problem-solving skills.