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

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.

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.
• 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

REQUIREMENTS:

• 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.
• Has 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
• Experience with leading complex development projects at an enterprise level
• Willing to travel
• Able to multi-task continuously

Required Skills:

Aerosol, Biomedical Engineering, Biopharmaceutical Industry, Biopharmaceuticals, Combination Products, Cross-Functional Communications, Design Controls, Device Development, Dry Powder Inhalers (DPI), Engineering Analysis, Extensive Traveling, Finite Element Analysis (FEA), Human Factor Engineering, Manufacturing Systems Development, Mechanical Testing, Medical Device Quality Systems, Process Development Engineering, Process Manufacturing, Product Risk Management, Pulmonary Drug Delivery, Risk Control, Risk Management, Self Motivation

Preferred Skills: