CONTRACT WORK:
Position Summary
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.
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.