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

Job Description

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. 

Job description

This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on inhalation drug-device combination product programs they lead to ensuring high quality products, robust manufacturing processes and appropriate integration of formulation, device, aerosol performance, patient use, and regulatory considerations. This position interacts extensively with subject-matter experts on the DPP team and members of internal cross-functional product development teams from concept through product launch.  Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. 

This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply their knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial inhalation combination product development and launches, including device-platform selection, drug-device interface definition, aerosol performance strategy, and patient-centric usability considerations.

Principal Responsibilities

• 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.
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• 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 as