Senior Principal Engineer, Spray Drying Process Development

Halozyme, Inc. • San Diego, CA

4d • $215,000 - $240,000

About The Position

The Senior Principal Engineer, Spray Drying Process Development, leads the 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 scalable platform processes and establishing relationships among formulation attributes, process parameters, particle properties, product quality, injectability, and stability. It applies engineering principles, design of experiments (DOE), statistical analysis, and process modeling to define critical process parameters (CPPs) and critical quality attributes (CQAs), establish process-control and scale-up strategies, and support transfer to CDMOs for clinical and commercial manufacturing.

The role works closely with Formulation, Analytical Development, Manufacturing, Quality, Regulatory, Device Development, Business Development, Alliance Management, and external partners. It leads hands-on spray-drying studies, process optimization and troubleshooting, powder handling and suspension-generation development, scale-up, manufacturing support, and technology transfer. It also provides technical mentorship, supports equipment and laboratory readiness, drives technical innovation and potential intellectual property, and authors or reviews development, characterization, transfer, and regulatory documentation.

Requirements

• BS in Chemical Engineering, Pharmaceutical Engineering, Process Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering or scientific discipline with 15 or more years of relevant experience; MS with 12 or more years; or PhD with 10 or more years. Equivalent combinations of education and experience may be considered.
• Significant pharmaceutical-industry experience in 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, preferably from aqueous feedstocks.
• Expertise in DOE, statistical analysis, multivariate analysis, and/or process modeling to establish process understanding, identify CPPs, assess 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.
• Demonstrated experience leading pharmaceutical process technology transfer and scale-up from laboratory through pilot and/or GMP manufacturing environments.
• Ability to establish technical strategies independently, identify technical risks and knowledge gaps, develop experimental plans, and lead execution across internal and external teams.
• Demonstrated technical leadership, independent problem-solving, and cross-functional influence.
• Regulatory experience, including authoring or supporting regulatory filing sections, preparing clear regulatory narratives from process-development and characterization data, and responding scientifically to health authority questions.
• Strong written and verbal communication skills, including authoring technical reports, SOPs, process-development and characterization reports, technology-transfer documents, and other development documentation.
• Ability to communicate complex engineering and process concepts to 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 laboratory spray-drying studies, translating results into process understanding and control strategies.
• Serve as technical lead for spray-drying process characterization, optimization, troubleshooting, scale-up, and manufacturing implementation.
• Establish relationships among feedstock and formulation attributes, equipment configuration, process parameters, particle and powder attributes, suspension performance, injectability, stability, and product quality.
• Design and execute statistically rigorous DOE studies; apply engineering principles, process modeling, and multivariate analysis to identify CPPs, characterize interactions, establish operating ranges, link process parameters to CQAs, and develop control strategies.
• Develop understanding of feedstock and formulation attributes, including concentration, viscosity, surface and interfacial properties, excipient composition, and molecule-specific characteristics, and their effects on process behavior and particle attributes.
• Partner with Formulation Development and Analytical Development to identify and characterize material attributes and CQAs from liquid feed through spray-dried powder and final suspension products.
• Lead development and characterization of powder handling and suspension-generation operations, including powder addition, wetting, dispersion, mixing, and hold time; assess their interactions with upstream spray-drying conditions.
• Maintain hands-on expertise with development-scale spray-drying equipment, including Büchi, ProCepT, GEA/Niro MOBILE MINOR®, and similar systems.
• Develop scale-up strategies across development, pilot, and manufacturing scales, assessing atomization technologies, drying behavior, heat and mass transfer, equipment configuration, and scale-dependent factors; define scale-comparability and transfer criteria.
• Partner with Manufacturing and CDMOs on engineering, scale-up, process-characterization, and manufacturing-support studies; troubleshoot technical issues and translate process understanding into manufacturing 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 during CDMO selection and evaluation, assessing spray-drying, powder-processing, suspension-generation, scale-up, and commercial-manufacturing capabilities.
• Support equipment selection, laboratory infrastructure, 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; promote best practices, technical growth, knowledge sharing, and organizational capability building.
• Drive technical innovation and identify potential intellectual property related to spray drying, particle engineering, suspension generation, scale-up, and integrated process/product understanding.
• Collaborate across internal functions and interface with CROs, CDMOs, consultants, equipment vendors, and development partners.
• Author and review process-development reports, characterization studies, technology-transfer packages, technical protocols, risk assessments, and other development and manufacturing documentation; follow safety, documentation, and applicable quality requirements.
• Perform other duties as assigned.

Benefits

• Comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities for learning, development, and progression through in-house programs and tuition reimbursement.
• Collaborative and innovative team environment.
• Base pay range of $215,000–$240,000 per year; total compensation could also include bonuses, sales incentives, and equity awards.

What This Job Offers

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