Principal Engineer – Global MSAT

• Provide project leadership for late-stage molecule process transfer/technology transfer for clinical and commercial biologics manufacturing
• Support development and maintenance of technical documentation for process control and validation strategies
• Support implementation of network alignment strategy
• Create global templates and documentation for technology transfer and new product introduction across the manufacturing network
• Provide onsite support for new facility or client startup engineering runs and performance qualification runs
• Assist in generating relevant regulatory submissions
• Support regulatory and site inspections
• Manage or provide direct reports/management of junior process engineers
• Lead site-to-site technology transfer activities
• Lead gap analyses and risk assessments, establish mitigation plans, and build design spaces for critical process parameters
• Support development, review, and approval of technical documentation, including global performance qualification protocols, batch records, and engineering/GMP/PPQ reports
• Lead development and implementation of templates for process validations and continued process verification strategies
• Lead process data analysis, including annual periodic reviews across manufacturing sites
• Develop process transfer documents and process control strategies for Phase III and commercial programs at receiving sites

• Bachelor’s degree in engineering science or related program with 12+ years relevant experience, or 8+ years of relevant experience with an MS
• Subject matter expertise in downstream processing, including downstream process chromatography, continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
• Knowledge of single-use bioreactors and perfusion technology
• Subject matter expertise in cell culture biopharmaceutical manufacturing or development of cell culture processes, including perfusion technologies, single-use bioreactor operations, and scale-up strategies
• Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/commercial campaign support
• Understanding of GMP concepts and quality systems
• Experience developing and overseeing continuous process monitoring strategies and process validation status throughout the commercial lifecycle
• Knowledge of manufacturing process lifecycle management principles
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support
• Solid background in statistical analysis
• Significant experience with process risk assessment tools such as FMEA and facilitating risk assessments
• Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems
• Strong focus on quality and attention to detail
• Effective task/time management and organizational skills
• Ability to organize, analyze/interpret, and translate downstream expertise into global procedures/templates
• Demonstrated skill managing and mentoring direct reports
• Recognized technical mastery of either upstream or downstream operations and continuous processing from bench-scale through commercial manufacturing scale
• Knowledge and expertise to solve complex technical problems and apply novel approaches
• Experience leading technical projects with external collaborators and vendors
• Ability to navigate global regulatory CMC documents
• Demonstrated initiative, flexibility, follow-through, and accountability

Demonstrates expertise in downstream processing and technology transfer for clinical and commercial biologics manufacturing, with a strong focus on regulatory compliance and process validation. Proven ability to lead projects, mentor teams, and develop technical documentation to support manufacturing operations.

• Downstream Processing Expertise
• Technology Transfer Leadership
• Regulatory CMC Document Authoring
• Process Validation Experience
• GMP Knowledge

• Downstream Process Chromatography
• Continuous Chromatography
• Large Scale Column Packing
• Viral Filtration
• Tangential Flow Filtration
• Single-Use Bioreactor Operations
• Process Risk Assessment Tools
• Statistical Analysis
• Process Control Strategies
• Process Validation Status Management

• Effective Task Management
• Organizational Skills
• Mentoring Skills
• Attention to Detail
• Problem-Solving Skills

• Biologics Manufacturing
• GMP Concepts
• Regulatory Submissions
• Process Lifecycle Management
• Commercial Qualification

• DeltaV Automation Systems
• Manufacturing Execution Systems
• Continuous Process Monitoring Strategies