MSAT Lifecycle Management Manager


Maryland
Permanent
USD110000 - USD180000
Research And Development
PR/547499_1748812094
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.

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