Material Excellence Engineer, Site MSAT

• Lead global dual-sourcing initiatives for lentiviral vector (LV) manufacturing materials under Project S.U.R.G.E.
• Lead process improvement projects focused on material reliability, supply resilience, manufacturing performance, and cost reduction.
• Develop and manage project plans, milestones, deliverables, and critical-path schedules for material dual-sourcing programs.
• Identify materials and vendors and develop URS documentation to support vendor qualification and sourcing activities.
• Conduct technical reviews of vendor drawings and support formal material comparability assessments.
• Define material quality attributes and implement associated change controls.
• Analyze manufacturing performance and develop initiatives to improve process robustness and operational efficiency.
• Conduct risk assessments and develop appropriate mitigation strategies.
• Implement processes supporting supply chain, logistics, and material distribution.
• Develop project analytics, schedules, and visual management tools to track key handoffs and transitions.
• Coordinate site and global MSAT activities with manufacturing, production, supply chain, vendors, and leadership stakeholders.
• Support pharmaceutical manufacturing operations in compliance with cGMP and applicable health authority requirements.

• Bachelor’s degree in Biochemistry, Biotechnology, Chemical Engineering, or a related scientific/engineering discipline required., * 5+ years of pharmaceutical or biotechnology industry experience.
• 3+ years of project management experience.
• Pharmaceutical/biotechnology manufacturing experience.
• Biological manufacturing processes, including upstream and downstream processing.
• Lentiviral vector or viral manufacturing knowledge.
• cGMP guidelines and pharmaceutical regulatory requirements, including FDA and EMA.
• Material specifications and quality attributes.
• User Requirements Specifications (URS).
• Change control development and implementation.
• Material comparability assessments.
• Vendor technical evaluation and qualification support.
• Manufacturing process improvement and process robustness.
• Risk assessment and mitigation.
• Supply chain, logistics, and material distribution processes.
• Microsoft Project.
• Microsoft Excel and PowerPoint.

Preferred Skills

• Advanced therapies or lentiviral vector manufacturing experience.
• Cell therapy manufacturing experience.
• Experience leading global material dual-sourcing programs.
• Experience in a global matrix pharmaceutical organization.
• PMP, CPM, or other professional project management certification.
• Experience with vendor drawings and technical specifications.
• Experience with manufacturing cost-reduction initiatives.
• Experience developing critical-path schedules and project analytics.