Senior Principal Engineer, Spray Drying Process Development

Halozyme • San Diego, CA

2d

About The Position

The Senior Principal Engineer, Spray Drying Process Development, will lead development, characterization, scale-up, and technology transfer of spray-drying processes for biotherapeutic formulations and particle-based delivery technologies. The role serves 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. It applies engineering principles, DOE, statistical analysis, and process modeling to define critical process parameters (CPPs) and critical quality attributes (CQAs), develop process-control and scale-up strategies, and lead transfers to CDMOs supporting clinical and commercial manufacturing.

The engineer will collaborate with Formulation, Analytical Development, Manufacturing, Quality, Regulatory, Device Development, Business Development, Alliance Management, and external partners to support robust processes across programs and therapeutic modalities. The role includes hands-on laboratory and development-scale spray-drying work, downstream powder handling and suspension generation, manufacturing support, technical documentation, mentorship, and identification of innovation and intellectual-property opportunities. The position also supports equipment selection, laboratory infrastructure, safety assessments, SOP development, and operational readiness.

Requirements

• BS in Chemical Engineering, Pharmaceutical Engineering, Process Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering or scientific discipline with 15+ years of relevant experience; or MS with 12+ years; or PhD with 10+ years. Postdoctoral experience may count, and an equivalent combination of education and experience may be considered.
• Significant industry experience in pharmaceutical spray-drying process development, characterization, scale-up, and/or manufacturing.
• Strong hands-on experience with development-scale spray-drying equipment such as ProCepT, Büchi B290/S300, GEA-Niro Mobile Minor, or comparable systems.
• Experience developing spray-dried biologic formulations; aqueous feedstocks are preferred.
• Expertise in DOE, statistical analysis, multivariate analysis, and/or process modeling to establish process understanding, identify CPPs, characterize robustness, and quantify relationships between process parameters and product quality attributes.
• Strong understanding of spray-drying engineering principles, including atomization, droplet formation, drying kinetics, heat and mass transfer, particle formation, and the effects of equipment configuration and operating conditions on particle properties.
• Understanding of spray-drying scale-up principles and ability to translate process knowledge across equipment configurations and manufacturing scales.
• Ability to independently establish technical strategies, identify technical risks and knowledge gaps, develop experimental plans, and lead execution across internal and external teams.
• Technical leadership, independent problem-solving ability, and cross-functional influence.
• Regulatory experience, including authoring and supporting relevant regulatory-filing sections, translating development and characterization data into regulatory narratives, and preparing scientifically sound responses to health-authority questions.
• Strong written and verbal communication skills, including the ability to author technical reports, SOPs, process-development and characterization reports, technology-transfer documentation, and other development documentation.
• Ability to communicate complex engineering and process concepts to formulation and analytical scientists, manufacturing teams, external partners, and senior leadership.
• Ability to work independently and collaboratively in a multidisciplinary environment.

Nice To Haves

• Experience with particle characterization, residual-moisture analysis, rheology, suspension performance, and protein analytical methods.
• Direct experience transferring spray-drying processes to CDMOs.
• Understanding of Quality, regulatory, and cGMP requirements for process development from Phase 1 through late-stage development, including aseptic-processing requirements.

Responsibilities

• Lead spray-drying process-development and characterization strategy, including scalable platform processes for multiple molecules, formulations, and therapeutic modalities.
• Design, execute, and interpret hands-on laboratory spray-drying studies and translate findings into process understanding and control strategies.
• Serve as technical lead for spray-drying process development, characterization, optimization, troubleshooting, scale-up, and manufacturing implementation.
• Establish relationships among feedstock and formulation attributes, equipment configuration, process parameters, particle and powder properties, suspension characteristics, injectability, stability, and product performance.
• Design and execute statistically rigorous DOE studies; apply engineering principles, process modeling, and multivariate analysis to identify CPPs, characterize parameter interactions, define operating ranges and relationships to CQAs, and develop process controls.
• Define platform-standardized elements and approaches for molecule-specific adaptation.
• Develop understanding of feedstock and formulation attributes, including concentration, viscosity, surface and interfacial properties, excipient composition, and molecule-specific characteristics, and their effects on processing and particle attributes.
• Establish relationships between particle and powder attributes and downstream suspension performance, stability, syringeability, injectability, and product quality.
• Partner with Formulation Development and Analytical Development to characterize relevant material attributes and CQAs from liquid feed through powder and final high-concentration suspension products.
• Lead development and characterization of powder handling and suspension-generation processes, including powder addition, wetting, dispersion, mixing, and hold time.
• Evaluate interactions between spray-drying conditions and downstream suspension performance to build integrated process and product understanding.
• Maintain hands-on expertise with development-scale spray-drying equipment, including Büchi, ProCepT, GEA/Niro MOBILE MINOR®, and comparable systems.
• Develop scale-up strategies across development, pilot, and manufacturing scales, assessing atomization, drying behavior, heat and mass transfer, equipment configuration, and scale-dependent factors.
• Establish engineering and product-quality criteria for scale comparability and process transfer.
• Partner with Manufacturing and CDMOs on engineering, scale-up, process-characterization, and manufacturing-support studies; troubleshoot issues and translate process understanding into commercial execution.
• Lead technology transfer for spray-drying, powder-handling, and suspension-generation processes, including process descriptions, operating ranges, equipment requirements, sampling strategies, scale-up rationale, transfer documentation, and comparability assessments.
• Provide technical leadership in CDMO selection and evaluation, assessing spray-drying, powder-processing, suspension-generation, scale-up, and commercial-manufacturing capabilities.
• Support equipment selection, laboratory infrastructure development, safety assessments, SOP development, and operational readiness for spray-drying, powder-handling, and suspension-generation operations.
• Provide technical leadership and mentorship to scientists and engineers and support technical growth, knowledge sharing, best practices, and organizational capability building.
• Drive technical innovation and identify opportunities for intellectual property related to spray drying, particle engineering, suspension generation, scale-up, and integrated process/product understanding.
• Collaborate cross-functionally and interface with CROs, CDMOs, consultants, equipment vendors, and development partners.
• Author and review process-development reports, process-characterization studies, technology-transfer packages, technical protocols, risk assessments, and other development and manufacturing documentation, following safety, documentation, and applicable quality requirements.
• Perform other duties as assigned.

Benefits

• Full and comprehensive benefit program
• Employee Stock Purchase Program
• 401(k) matching
• In-house learning and development programs
• Tuition reimbursement
• Opportunities for career growth and progression
• Bonuses, sales incentives, and equity awards may be included in total compensation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior