Tangential Flow Filtration (TFF) Subject Matter Expert

We are seeking a highly experienced Tangential Flow Filtration (TFF) Subject Matter Expert to provide technical leadership and support for pharmaceutical process development and manufacturing activities. The ideal candidate will have deep, hands-on expertise in TFF process development, scale-up, optimization, troubleshooting, validation, and implementation within a regulated pharmaceutical environment. This individual should be capable of independently evaluating complex technical issues and developing practical, scientifically sound solutions.

Key Responsibilities

• Serve as the technical SME for TFF process development, scale-up, optimization, troubleshooting, and validation
• Develop and evaluate TFF processing strategies and operating approaches
• Assess critical process parameters, operating ranges, membrane selection, flux, pressure, concentration and diafiltration strategies, processing time, and other factors affecting process performance
• Support scale-up and implementation of TFF processes in GMP manufacturing environments
• Develop and support process characterization and validation strategies
• Provide technical input into protocols, reports, risk assessments, process descriptions, control strategies, and supporting documentation
• Provide technical support for regulatory interactions and responses related to process development, validation, and manufacturing strategy
• Troubleshoot filtration performance, membrane behavior, fouling, yield, process efficiency, and scale-up challenges
• Work directly with equipment, membrane, and system vendors to resolve technical issues and evaluate proposed solutions
• Collaborate with EH&S and other technical functions on applicable process safety and environmental considerations
• Work cross-functionally with Process Development, Manufacturing, Engineering, Validation, Quality, Regulatory, and other technical groups as required

Required Experience And Qualifications

• Significant pharmaceutical industry experience with Tangential Flow Filtration, with sufficient technical depth to function independently as a TFF SME
• Demonstrated experience developing, scaling, troubleshooting, and validating TFF processes
• Strong knowledge of TFF system design, membrane selection, operating parameters, process characterization, scale-up principles, and filtration performance
• Experience supporting GMP pharmaceutical manufacturing operations
• Experience developing or supporting process validation strategies
• Experience providing technical support for regulatory interactions, submissions, or responses involving pharmaceutical manufacturing processes
• Demonstrated ability to work directly with equipment and membrane vendors and critically evaluate vendor recommendations
• Strong technical problem-solving and troubleshooting capabilities
• Ability to develop and defend scientifically sound technical recommendations
• Strong cross-functional communication skills and the ability to work effectively with technical, quality, regulatory, engineering, and manufacturing organizations

Preferred Experience

• Experience supporting complex pharmaceutical manufacturing processes
• Experience with technology transfer and manufacturing process implementation
• Experience supporting process characterization and process performance qualification activities
• Experience with equipment design review, commissioning, qualification, and implementation