Scientist III, Injectable Drug Product Development

This is what you will do: 

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 submissions (e.g., IND/IMPD, BLA/MAA), including process descriptions, comparability assessments, and responses to regulatory queries. 

• Cross-Functional Collaboration — Partnering with Analytical Sciences & QC, Drug Substance Process Development, Device Development, Manufacturing Technical Services, Quality Assurance, and CMC Regulatory Affairs to align development plans and ensure on-time program delivery. 

• Team Leadership — Managing and mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence. 

• Communication & Initiative — Presenting program status, risks, and recommendations clearly to senior management and cross-functional teams; taking initiative to solve scientific and operational challenges. 

• Safety & Laboratory Operations — Operating primarily in a laboratory environment and complying with all safety procedures; with or without accommodation, able to lift/carry 15/30 pounds (unassisted/assisted) and work around biological, infectious, and hazardous materials while maintaining a safe, orderly workspace. 

You will need to have: 

• Education — 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. 

• End-to-End Drug Product Development Experience — Demonstrated history of leading or significantly contributing to injectable/parenteral biologic drug product development across the full lifecycle: formulation development, process development, and technology transfer to manufacturing. This is a core requirement. 

• Process Engineering & Modeling Expertise — 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). Ability to apply first-principles engineering and computational tools to predict and solve scale-dependent manufacturing challenges. 

• Formulation & Protein Science Foundation — Scientific and practical knowledge of protein biochemistry, biophysics, protein formulation, and stability for parenteral biologics. 

• Hands-On Laboratory Capability — Ability to design, execute, and troubleshoot laboratory studies; generate high-quality data using biophysical and analytical instrumentation. 

• Collaboration & Communication — 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. 

• Problem Solving & Strategic Thinking — 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. 

• Work Environment — Able, with or without accommodation, to lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging. 

We would prefer you to have: 

• Technical Development Project Execution — 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. 

• Process Engineering and Scale-Up  

• Regulatory & Quality Knowledge — Familiarity with global regulatory guidances (ICH, FDA, EMA), cGMPs, and Quality/Compliance expectations for the development of parenteral biologics and gene therapy vectors. 

• Digital & Data Tools — Experience with electronic lab notebooks, statistical software (JMP/Minitab), process simulation software, MS Office (Word, PowerPoint, Excel), GraphPad, Visio, Adobe Pro, and EndNote; experience maintaining laboratory instrumentation (preventative maintenance, data backup, software upgrades). 

• Manufacturing Exposure — Direct experience supporting GMP manufacturing, process validation campaigns, or CDMO management.