Principal Scientist, Biotherapeutic Formulations

Halozyme • San Diego, CA

5d

About The Position

The Principal Scientist, Formulations provides scientific and technical leadership for formulation development and characterization of partner biotherapeutics using Halozyme’s proprietary excipient and spray-drying platform. The role develops robust formulations across the pathway from partner-provided feedstock through spray drying and powder characterization to final high-concentration suspensions, optimizing conditions to maintain molecular stability, product quality, manufacturability, and performance during processing and storage.

The position operates with a high degree of independence, designing and executing laboratory experiments, applying DOE and statistical approaches, and building structure-property-process understanding across partner molecules and modalities. It collaborates with Analytical Development, Process Development, and Manufacturing, and works directly with external partners to design studies, interpret results, troubleshoot challenges, and advance programs. The Principal Scientist also contributes to platform innovation and intellectual property, provides technical mentorship, and supports partner interactions, technical due diligence, and evaluation of new molecule opportunities.

Requirements

• PhD in a scientific discipline such as Pharmaceutical Sciences, Materials Science, or Chemical Engineering, with 10 or more years of relevant experience; postdoctoral experience may count.
• Deep expertise in biologics formulation development and protein stability, with demonstrated experience developing formulations for therapeutic proteins and/or other complex biotherapeutic modalities.
• Strong understanding of protein degradation and instability mechanisms and formulation approaches used to mitigate them.
• Demonstrated experience designing and executing accelerated and real-time stability studies and interpreting stability-indicating analytical and biophysical data.
• Strong understanding of formulation variables including pH, buffer systems, ionic strength, excipients, protein concentration, viscosity, and solution-to-solid-state transitions and their effects on product stability.
• Hands-on experience with analytical and biophysical characterization techniques relevant to biologics formulation and stability, potentially including chromatography, particle/subvisible particle characterization, protein concentration, rheology/viscosity, thermal stability, light scattering, spectroscopy, moisture analysis, and powder characterization.
• Strong knowledge of statistical principles and proficiency with statistical software for experimental design, data analysis, process optimization, and formulation development.
• Demonstrated ability to define technical strategy, solve complex formulation challenges, and drive scientific decision-making across multiple programs.
• Scientific creativity and independent thought, with the ability to mentor scientists and influence cross-functional teams.
• Ability to independently organize, prioritize, and lead multiple complex workstreams while adapting to changing business needs and timelines.
• Demonstrated ability to work directly with external scientific partners, jointly developing experimental plans, presenting data, responding to technical questions, and aligning on next-step studies.
• Effectiveness in multidisciplinary environments involving internal teams, external partners, consultants, CROs, and vendors.
• Excellent written and verbal communication skills, including the ability to convey complex scientific concepts to diverse audiences.
• An equivalent combination of experience and education may be considered.

Nice To Haves

• Experience with high-concentration formulations, spray drying, particle engineering, or suspension-based delivery.
• Experience characterizing biologics across solution, solid/powder, and concentrated suspension states.

Responsibilities

• Lead formulation development for platform and partner molecules using the company’s proprietary excipient and spray-drying technology.
• Develop, optimize, and characterize formulations from feedstock through spray drying, powder generation, and final high-concentration suspensions, ensuring molecular stability, product quality, manufacturability, and performance.
• Design and execute stability studies evaluating the effects of formulation composition, processing conditions, concentration, storage conditions, and time on product quality and performance.
• Perform and interpret biophysical characterization of biologic feedstocks, formulation intermediates, spray-dried powders, and final suspensions to understand degradation pathways, physical stability, and formulation performance.
• Independently develop experimental hypotheses, study designs, protocols, and data-analysis approaches, including DOE methodologies.
• Establish formulation-development workflows and screening strategies, analyze data using statistical tools, and translate findings into formulation decisions and program recommendations.
• Lead formulation activities across multiple partner programs and contribute to platform innovation and intellectual property development.
• Collaborate with Analytical Development, Process Development, and Manufacturing to optimize product performance and manufacturability.
• Serve as a formulation subject matter expert in partner interactions, technical due diligence, business development activities, and evaluation of new molecule opportunities.
• Develop fit-for-purpose formulation-development plans based on molecule characteristics, stability risks, and target product profiles.
• Build technical relationships with partners and communicate formulation rationale, experimental results, risks, and recommendations to internal and external stakeholders.
• Author and review technical reports, regulatory-supporting documents, publications, and presentations while complying with cGMP, safety, and documentation requirements.
• Maintain scientific expertise through literature review, conferences, industry benchmarking, and knowledge sharing.
• Provide technical mentorship to scientists and oversee external collaborations as needed.
• Perform other duties as assigned.

Benefits

• Comprehensive benefits 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, innovative team environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree