Principal Process Engineer - Site Based, Redmond, WA

Responsibilities Provide project leadership for late-stage molecule process transfer/tech transfer for clinical and commercial biologics manufacturing. Lead site-to-site tech transfer activities. Perform gap analysis/risks assessments; ensure mitigation plans are in place. Build design spaces (PAR & NOR ranges) for critical process parameters to support validation and late-stage/commercial manufacturing. Support development, review, and approval of technical documentation (global performance qualification protocols, batch records, and engineering/GMP/PPQ run reports). Develop and implement templates for Process Validations and Continued Process Verification strategies. Lead analysis of process data, including annual periodic reviews across the manufacturing site network. Develop process transfer documents and/or process control strategy for Phase III and commercial programs for receiving sites. Support network alignment strategy implementation and creation of global tech transfer/new product introduction templates/documentation across the manufacturing network. Provide onsite support for new facility/client startup engineering runs and performance qualification runs. Assist generation of regulatory submissions; support regulatory and site inspections. May manage direct reports/junior process engineers. Qualifications Bachelor’s degree in engineering science or related field with 12+ years relevant experience, or 8+ years with an MS. Subject matter expertise in downstream processing (chromatography, continuous chromatography, large-scale column packing, viral filtration, tangential flow filtration) and knowledge of single-use bioreactors and perfusion technology. Subject matter expertise in cell culture biopharmaceutical manufacturing/development (perfusion technologies, single-use bioreactor operations, scale-up strategies). Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial PPQ campaigns. Understanding of GMP concepts and quality systems for process transfer and validation. Experience with continuous process monitoring strategies and process validation status across the commercial lifecycle. Ability to apply manufacturing process lifecycle management principles to establish and improve process control strategies. Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and supporting inspections. Solid background in statistical analysis. Significant experience with process risk assessment tools (e.g., FMEA) and facilitating risk assessments. Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems. Strong quality focus, attention to detail, and task/time management. Strategic mindset; ability to translate downstream expertise into global procedures/templates. Demonstrated skill managing and mentoring direct reports. Preferred Qualifications Technical mastery of upstream or downstream operations and continuous processing from bench-scale through commercial scale. Ability to solve complex technical problems; apply novel approaches. Experience leading technical projects with external collaborators and vendors. Ability to navigate global regulatory CMC documents. High initiative, flexibility, follow-through, and accountability. #J-18808-Ljbffr Scorpion Therapeutics