Scientist III, Injectable Drug Product Development

Scientist III

The Scientist III will be a key member of the Injectable Drug Product Development (IDPD) team, responsible for driving end-to-end drug product development—from candidate selection through commercial validation and regulatory filing—for parenteral/injectable biologic products. This role demands deep expertise in formulation development, process development, process engineering, scale-up modeling, and technology transfer, leveraging first-principles engineering, computational modeling, and simulation tools to deliver robust, scalable drug products.

You will apply strong process engineering fundamentals to design, model, optimize, and scale drug product manufacturing processes (e.g., mixing, filtration, fill/finish unit operations, hold steps, viscosity management). You will employ process modeling and simulation approaches (e.g., CFD, heat/mass transfer models, DoE-driven process models) to predict scale-dependent behavior, de-risk manufacturing, and support technology transfer to internal and external manufacturing sites.

You will provide scientific leadership for phase-appropriate formulation development of diverse biologic modalities—including monoclonal antibodies (mAbs), enzymes, enzyme fusion proteins, peptides, and AAV gene therapies—informed by biophysical and biochemical characterization data. You will integrate complex datasets to translate findings into formulation compositions, process parameters, control strategies, technical reports, and regulatory filings.

This position interacts regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Device Development, Manufacturing Technical Services, Quality Assurance, and CMC Regulatory Affairs.

You will be responsible for:

• End-to-End Drug Product Development — Leading formulation development, process development, and technology transfer activities across the full product lifecycle (candidate selection → clinical supply → commercial validation → regulatory filing), translating program goals into experimental plans, decision criteria, timelines, and risk mitigation strategies.
• Process Engineering & Scale-Up — Designing, optimizing, and scaling drug product unit operations (compounding/mixing, sterile filtration, fill/finish, freeze–thaw, hold steps, viscosity management) using engineering fundamentals, dimensional analysis, and scale-up correlations; conducting robustness and characterization studies to define process design space and critical process parameters.
• Process Modeling & Simulation — Applying computational tools and simulation approaches (e.g., CFD, mechanistic/empirical process models, heat and mass transfer calculations, DoE-based predictive models) to inform process design, predict scale-dependent effects, support equipment selection, and accelerate development timelines.
• Technology Transfer — Leading or supporting tech transfer of drug product processes to internal and external (CDMO) manufacturing sites; authoring process descriptions, batch record inputs, and process validation strategies; troubleshooting manufacturing issues and providing on-site support as needed.
• Formulation Development — Driving phase-appropriate formulation screening, optimization, and selection for injectable biologics using rational design principles informed by biophysical characterization, stability data, and structure–function relationships.
• Biophysical & Analytical Characterization — Designing and executing laboratory studies using advanced biophysical/analytical methods (e.g., DSC, nanoDSF, CD, fluorescence spectroscopy, SEC-MALS, DLS, AUC, CE-SDS/cIEF, subvisible particle analysis, rheology, viscosity profiling) to support formulation and process decisions; firsthand laboratory work is required.
• Data Integration & Control Strategy — Integrating complex datasets to establish structure–function relationships, degradation pathways, and mechanism-informed models; translating insights into robust formulations, control strategies, and phase-appropriate specifications.
• Regulatory & Documentation — Authoring protocols, technical reports, and contributing to CMC sections of regulatory…