Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equ

Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)

Our company’s Device Product Platforms (DPP) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPP Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration, with this role focused primarily on inhalation drug-device combination products, including dry powder inhalers, nebulized therapies, and other respiratory delivery platforms.

• Provide inhalation subject-matter leadership across dry powder inhaler, nebulized and other respiratory delivery programs, including assessment of device-platform options, drug-device compatibility, dose delivery performance, aerosol characterization strategy, device usability, clinical supply readiness and transition to commercial manufacturing.
• Lead and set direction for the device development strategy for multiple inhalation drug-device combination product development programs ranging from concept generation/selection, platform assessment, feasibility, development, verification, validation, and clinical/commercial launch readiness:
  • Lead the cross-functional Device Working Groups to ensure full integration of the inhalation product drug/device development activities with the clinical, regulatory, formulation, commercial, human factors, quality and manufacturing functions, including alignment on device selection, aerosol performance, dose delivery, and patient-use requirements.
  • Lead the Device Development Engineering Core teams focused on development of design requirements for the inhalation combination product and engineering execution against established requirements, including device performance and through-life stability, emitted dose, aerodynamic particle size distribution, robustness, usability, and manufacturability.
  • Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).
  • Serve as key point-of-contact with external specialist inhalation CDMOs, inhalation device designers/developers, component suppliers and manufacturing partners for drug-device combination product development, clinical supply, commercial manufacturing, and device technology platform activities.
  • Oversee and serve as a technical integrator of inhalation drug-device combination product development activities, including CDMO and/or site selection, formulation-device compatibility, device-platform assessment, manufacturing unit operations definition, clinical and commercial readiness, device engineering design, aerosol performance testing, engineering analysis, drug-device combination product design controls, risk management, inhalation-specific test method development, design verification and validation, component manufacture, automated assembly, container closure/device interface considerations, and human factors analysis.
  • Proactively anticipate and resolve project obstacles and effectively communicate complex inhalation product technical challenges, including device performance, formulation-device compatibility, aerosol delivery, manufacturability, usability, regulatory expectations, timelines, milestones, and risks within our Company and with external suppliers.
  • Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership, including content related to device description, design controls, risk management, human factors, aerosol performance, manufacturing process, and control strategy.
  • Lead/support/oversee clinical supplies production with respect to drug-device combination product and/or device component manufacture and final assembly of biologic/drug product with device constituent part.
  • Lead/support the development, implementation…