Principal Scientist, Biotherapeutic Formulations

Halozyme, Inc.•San Diego, CA

6d•$170,000 - $200,000

About The Position

The Principal Scientist, Formulations, provides scientific and technical leadership for developing and characterizing partner biotherapeutic formulations 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, and performance during processing and storage. Working with a high degree of independence, the Principal Scientist designs and executes laboratory experiments, applies design-of-exexperiments (DOE) and statistical approaches, and develops structure-property-process relationships across partner molecules and modalities. The position works closely with Analytical Development, Process Development, and Manufacturing, and directly with external partners to design studies, interpret results, troubleshoot technical challenges, and advance programs. The role also contributes to platform innovation, intellectual property, partner-facing technical activities, technical documentation, and scientific mentorship.

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; examples may include 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.
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.
Ability to work directly with external scientific partners, jointly develop experimental plans, present data, respond to technical questions, and align 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 explain 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 is strongly preferred.
Experience characterizing biologics in solution, solid/powder, and concentrated suspension states is highly desirable.

Responsibilities

Lead formulation development for platform and partner molecules using the proprietary excipient and spray-drying technology, from feedstock through spray drying, powder generation, and final high-concentration suspensions.
Design and execute stability studies assessing 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.
Develop hypotheses, study designs, protocols, and data-analysis approaches, including DOE methodologies; establish workflows and screening strategies and use data to guide 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, and evaluation of new molecule opportunities.
Develop fit-for-purpose formulation plans based on molecule characteristics, stability risks, and target product profiles.
Build technical relationships with partners and communicate formulation rationale, results, risks, and recommendations to internal and external stakeholders.
Author and review technical reports, regulatory-supporting documents, publications, and presentations, while following cGMP, safety, and documentation requirements.
Maintain scientific expertise through literature review, conferences, industry benchmarking, and knowledge sharing.
Mentor scientists and oversee external collaborations as needed.
Perform other duties as assigned.