Formulation director

Position Summary

We are seeking an experienced and highly motivated formulation director to join our Biologics CMC R&D team. This role will lead the development of high-concentration formulation CMC platform. The successful candidate will provide scientific leadership in formulation design, developability assessment, drug-device compatibility, and support the advancement of candidates from early development through commercialization.

Key Responsibilities：

Scientific Leadership

Lead the strategy, development, and continuous innovation of the company's High-Concentration Formulation Platform to support diverse biologic modalities

.Develop formulation strategies to address key developability challenges, including high viscosity, aggregation, opalescence, phase separation, particle formation, and syringeability

.Establish scientific understanding of protein stability mechanisms and leverage predictive and mechanistic approaches to accelerate formulation development

.Introduce state-of-the-art formulation technologies, high-throughput screening methodologies, and digital tools to enhance platform capabilities

.Drug Device & Drug Product Developmen

tLead formulation development for combination products, ensuring compatibility with drug delivery devices such as prefilled syringes, autoinjectors, and wearable injectors

.Provide technical leadership for device-related risk assessments and design verification activities

.CMC Development

Support formulation development through IND-enabling studies, clinical development, and commercial lifecycle management

.Provide formulation expertise during technology transfer, process validation, and commercial manufacturing

.Support fill-finish process development, manufacturing investigations, and scale-up activities

.People Leadershi

pBuild, mentor, and lead a high-performing team of formulation scientists

.Foster a culture of scientific excellence, innovation, collaboration, and continuous learning

.Qualification

sEducatio

• nPh.D. in Pharmaceutical Sciences, Protein Sciences, Chemical Engineering, Bioengineering, or a related discipline

.Experienc

• e5+ years of industry experience in biologics formulation development
• .Extensive experience developing high-concentration protein formulations for therapeutic antibodies and other complex biological modalities
• .Strong understanding of protein chemistry, biophysics, colloidal science, and formulation stability
• .Demonstrated experience supporting combination product development involving prefilled syringes, autoinjectors, or other injectable delivery systems
• .Working knowledge of fill-finish manufacturing processes and aseptic drug product manufacturing

.Preferred Qualification

• sExperience supporting late-stage CMC development, technology transfer, and commercial manufacturing
• .Thorough understanding of Quality by Design (QbD), Design of Experiments (DoE), and digital formulation development tools
• .Track record of publications, patents, or successful platform development initiatives

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