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

About the role

The Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent) is responsible for setting strategic direction on inhalation drug-device combination product programs, ensuring high quality products, robust manufacturing processes, and appropriate integration of formulation, device, aerosol performance, patient use, and regulatory considerations.

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).
• 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 and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.
• Maintain a high level of engagement in the program-specific design controls process and design history file development, ensuring inhalation-specific user needs, design inputs, aerosol and inhalation device performance requirements, risk controls, verification evidence and validation strategy are appropriately captured.
• Stay current with new inhalation delivery technologies, respiratory device platforms, relevant worldwide regulations, standards, regulatory expectations and industry developments for orally inhaled and nasal drug products, and effectively share this knowledge with others.
• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.

Qualifications

• B.A./B.S in Pharmaceutical, Science, Biomedical or Engineering-related subject plus a minimum of 10 years of combined experience in, (bio)pharmaceutical, medical device and combination product development. Advanced degree is preferred.
• 5+ years of leadership experience with deep working knowledge of device, biologic/drug product and process development including regulatory submission and approval processes. Experience with development of inhalation drug products, inhalation drug-device combination products, or respiratory device components is strongly preferred.
• 5+ years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams.
• Broad knowledge of medical device development, design controls and risk management, alongside deep knowledge of inhalation device design, requirements management, device and aerosol performance verification, automation/process development, design validation, human factors and control strategy.
• Knowledge of U.S. and global drug-device combination product and medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc. Knowledge of regulatory expectations and guidance for orally inhaled and nasal drug products, inhalation combination products, device performance, aerosol characterization, and patient-use considerations is strongly preferred.
• Proven track record of applying analytical and technical judgment to inhalation product and/or manufacturing process design, development, validation and lifecycle management, including interpretation of device, aerosol, formulation, and process performance data.
• Self-motivated with ability to work independently
• Proven ability to lead team members of different skill sets and backgrounds
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership
• Excellent communication, presentation, negotiation, project management, and organizational skills
• Proven ability to lead team members of different skill sets and backgrounds
• Willing to travel
• Able to multi-task continuously