Senior Principal Engineer, Spray Drying Process Development

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.   In order to move forward, you will need to create an account.   Your password must be eight characters long, contain at least one special character, one capital letter and a number.  We look forward to discovering your talents. Welcome to an inspired career. At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive. Join us as a Senior Principal Engineer , and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives. How you will make an impact The Senior Principal Engineer, Spray Drying Process Development, will lead the development, characterization, scale-up, and technology transfer of spray-drying processes for biotherapeutic formulations and particle-based delivery technologies. This role will serve as a technical authority, developing robust and scalable platform processes and establishing relationships between formulation attributes, process parameters, particle properties, product quality, injectability, and stability. Using engineering principles, DOE, statistical analysis, and process modeling, the role will define CPPs and CQAs, develop process-control and scale-up strategies, and lead technology transfer to CDMOs supporting clinical and commercial manufacturing. The Senior Principal Engineer will collaborate closely with Formulation, Analytical Development, Manufacturing, Quality, Regulatory, and external partners to ensure robust and scalable processes across multiple programs and therapeutic modalities. In this role, you’ll have the opportunity to: Lead spray-drying process development and characterization strategy, including development of scalable platform processes capable of supporting multiple partner molecules, formulations, and therapeutic modalities. Design, execute, and interpret hands-on laboratory spray-drying studies and translate findings into actionable process understanding and control strategies. Serve as the technical lead for spray-drying process development, characterization, optimization, troubleshooting, scale-up, and manufacturing implementation. Establish a systematic understanding of the relationships among feedstock and formulation attributes, equipment configuration, process parameters, particle properties, powder performance, suspension characteristics, injectability, stability, and overall product performance. Design and execute statistically rigorous DOE studies and apply engineering principles, process modeling, and multivariate analysis to identify CPPs, characterize parameter interactions, establish acceptable operating ranges, define relationships to CQAs, and develop robust process-control strategies. Define elements that can be standardized within the platform while establishing approaches for molecule-specific adaptation when required. Develop deep process understanding of feedstock and formulation attributes, including concentration, viscosity, surface and interfacial properties, excipient composition, and molecule-specific characteristics, and their impact on spray-drying behavior, process robustness, and resulting particle attributes. Establish relationships between particle and powder attributes, including particle size distribution, morphology, density, residual moisture, solid-state properties, and drug loading, and downstream suspension performance, stability, syringeability, injectability, and product quality. Partner closely with Formulation Development and Analytical Development to identify and characterize relevant material attributes and CQAs from liquid feed through spray-dried powder and final high-concentration suspension products. Lead development and characterization of downstream powder handling and suspension-generation processes, including powder addition, wetting, dispersion, mixing, hold time, and related unit operations. Evaluate interactions between upstream spray-drying conditions and downstream suspension performance to establish integrated process and product understanding. Maintain strong hands-on operational expertise with development-scale spray-drying equipment, including Büchi, ProCepT, GEA/Niro MOBILE MINOR®, and similar systems, and use experimental findings to guide process optimization, scale-up, and commercial implementation. Develop and execute scale-up strategies across development, pilot, and manufacturing scales, including assessment of atomization technologies, drying behavior, heat and mass transfer, equipment configuration, and other scale-dependent factors. Establish engineering and product-quality criteria for scale comparability and process transfer. Partner closely with Manufacturing and external CDMOs to design and execute engineering, scale-up, process characterization, and manufacturing-support studies. Troubleshoot technical issues and ensure effective translation of process understanding into commercial execution. Lead the technical aspects of technology transfer for spray-drying, powder-handling, and suspension-generation processes, including development of process descriptions, operating ranges, equipment requirements, sampling strategies, scale-up rationale, transfer documentation, and comparability assessments. Provide technical leadership during CDMO selection and