Senior Principal Engineer, Spray Drying Process Development

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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 evaluation, assessing capabilities related to spray drying, powder processing, suspension generation, scale-up, and commercial manufacturing.
• 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, fostering scientific excellence and establishing best practices in spray drying, process characterization, scale-up, technology transfer, and process development. Support technical growth, knowledge sharing, and capability building across the organization.
• Drive technical innovation and identify opportunities for intellectual property generation related to spray-drying processes, particle engineering, suspension generation, scale-up, and integrated process/product understanding.
• Collaborate cross-functionally with Manufacturing, Formulation Development, Analytical Development, Quality, Regulatory, Device Development, Business Development, and Alliance Management, 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 while ensuring compliance with safety requirements, documentation practices, and applicable quality standards.
• Other duties as assigned.

To succeed in this role, you’ll need:

• Minimum of a 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; MS with 12+ years of relevant experience; or PhD with 10+ years of relevant experience preferred (may include postdoctoral experience). An equivalent combination of experience and education may be considered.
• Significant industry experience in pharmaceutical spray-drying process development, characterization, scale-up, and/or manufacturing, with strong hands-on experience using development-scale spray-drying equipment such as ProCepT, Buchi B290/S300 or GEA-Niro Mobile Minor or comparable systems.
• Experience developing spray-dried biologic formulations, preferably from aqueous feedstocks.
• Demonstrated expertise in DOE, statistical analysis, multivariate analysis, and/or process modeling to establish process understanding, identify CPPs, characterize process 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 relationships among equipment configuration, operating conditions, and resulting particle properties.
• Demonstrated understanding of scale-up principles for spray-drying processes and the ability to translate process knowledge across different equipment configurations and manufacturing scales
• Experience with particle characterization, residual moisture analysis, rheology, suspension performance, and protein analytical methods preferred.
• Demonstrated experience leading technology transfer and scale-up of pharmaceutical processes from laboratory through pilot and/or GMP manufacturing environments; direct experience transferring spray-drying processes to CDMOs strongly preferred. Ability to independently establish technical strategies, identify key technical risks and knowledge gaps, develop experimental plans to address them, and lead execution across internal and external teams.
• Demonstrated technical leadership, independent problem-solving ability, and cross-functional influence.
• Demonstrated regulatory experience, including the ability to author and support relevant sections of regulatory filings, translate process-development and characterization data into clear regulatory narratives, and prepare scientifically sound responses to health authority questions. Understanding of Quality, regulatory, and cGMP requirements for process development from Phase 1 through late-stage development is highly desired, including an understanding of aseptic processing requirements.
• Strong written and verbal communication skills with the ability to author technical reports, SOPs, process-development and characterization reports, technology-transfer documentation, and development documentation.
• Demonstrated ability to communicate complex engineering and process concepts to formulation scientists, analytical scientists, manufacturing teams, external partners, and senior leadership.
• Ability to work independently and collaboratively in a multidisciplinary environment.

In return, we offer you:

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact - on your career, the work you do and patients’ lives.

The most likely base pay range for this position is $215K - $240K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at hrbox@halozyme.com.

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.