Scientist III, Injectable Drug Product Development

This Is What You Will Do

• Leading formulation development, process development, and technology transfer activities across the full product lifecycle (candidate selection → clinical supply → commercial validation → regulatory filing)
• Designing, optimizing, and scaling drug product unit operations (compounding/mixing, sterile filtration, fill/finish, freeze–thaw, hold steps, viscosity management)
• 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
• 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
• 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
• 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
• Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions (e.g., IND/IMPD, BLA/MAA), including process descriptions, comparability assessments, and responses to regulatory queries

Responsibilities

• Leading or significantly contributing to injectable/parenteral biologic drug product development across the full lifecycle: formulation development, process development, and technology transfer to manufacturing
• Strong background in process engineering principles, process modeling, simulation (e.g., CFD, mechanistic models, empirical scale-up correlations), and scale-up of drug product unit operations (fill/finish, mixing, filtration, hold steps)
• Scientific and practical knowledge of protein biochemistry, biophysics, protein formulation, and stability for parenteral biologics
• Ability to design, execute, and troubleshoot laboratory studies; generate high-quality data using biophysical and analytical instrumentation
• Excellent interpersonal skills; strong ability to communicate effectively across functions and levels; proven ability to mentor and motivate team members within the department and in matrix/cross-functional teams
• Makes strategic scientific/technical proposals aligned with corporate and project objectives; takes initiative in problem solving and delivering solutions to complex scientific and engineering challenges

Requirements

• PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, or a relevant field with 5+ years of industry experience; or MS with 14+ years or BS with 15+ years of relevant experience
• Experience leading or managing technical development projects end-to-end, including planning, resourcing, timeline management, risk assessment, and decision governance within a pharmaceutical/biotech development environment
• Familiarity with global regulatory guidances (ICH, FDA, EMA), cGMPs, and Quality/Compliance expectations for the development of parenteral biologics and gene therapy vectors
• Experience with electronic lab notebooks, statistical software (JMP/Minitab), process simulation software, MS Office (Word, PowerPoint, Excel), GraphPad, Visio, Adobe Pro, and EndNote
• Direct experience supporting GMP manufacturing, process validation campaigns, or CDMO management