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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