Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Establish both tactical and strategic direction for inhalation drug-device combination product initiatives.

• Oversee inhalation subject-matter activities related to dry powder inhalers, nebulized therapies, and various respiratory delivery programs.

• Direct device development strategies from concept generation and platform evaluation to feasibility, development, verification, validation, and readiness for launch.

• Facilitate cross-functional Device Working Groups that incorporate clinical, regulatory, formulation, commercial, human factors, quality, and manufacturing activities.

• Guide Device Development Engineering Core teams in defining design requirements and executing engineering tasks.

• Represent Device Development and Device Working Groups in cross-functional development and commercialization teams.

• Collaborate with external inhalation CDMOs, device designers/developers, component suppliers, and manufacturing partners.

• Supervise the technical integration of formulation-device compatibility, device assessment, manufacturing, aerosol performance testing, design controls, risk management, verification, validation, assembly, and human factors activities.

• Proactively identify and address technical and project challenges while communicating obstacles, risks, timelines, and milestones.

• Create and assess regulatory submission content for INDs, IMPDs, NDAs, BLAs, and associated combination product programs.

• Lead or assist in the production of clinical supplies, manufacturing of device components, and final assembly.

• Enhance Device Development and Device Project Leader processes, procedures, and tools.

• Maintain design controls and develop design history files, which include user needs, design inputs, risk controls, verification evidence, and validation strategies.

• Stay abreast of inhalation technologies, respiratory platforms, regulations, standards, and industry advancements.

• Elevate the company’s professional reputation through publications, presentations, patents, and professional engagements.

⛳️ Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Biomedical Sciences, Engineering, or a related field.

• At least 10 years of cumulative experience in biopharmaceuticals, medical devices, and combination product development.

• Over 5 years of leadership experience in device and biologic/drug product development, including navigating regulatory submission and approval processes.

• More than 5 years of leadership experience overseeing complex device or combination product development programs and managing cross-disciplinary project teams.

• Comprehensive understanding of medical device development, design controls, and risk management practices.

• Extensive knowledge of inhalation device design, requirements management, device and aerosol performance verification, automation/process development, design validation, human factors, and control strategies.

• Familiarity with U.S. and international regulations concerning drug-device combination products, medical devices, and healthcare.

• Understanding of FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO standards, and relevant directives.

• Demonstrated experience in applying analytical and technical judgment in the design, development, validation, and lifecycle management of inhalation products or manufacturing processes.

• Proficient in interpreting performance data related to devices, aerosols, formulations, and processes.

• Capable of working autonomously and leading team members with diverse skills and backgrounds.

• Skilled in influencing without formal authority and effectively presenting ideas to senior leadership.

• Exceptional communication, presentation, negotiation, project management, and organizational abilities.

• Experience managing complex development projects at the enterprise level.

• Willing to travel as needed.

• Ability to manage multiple tasks simultaneously.

• Strong preference for experience with inhalation drug products, inhalation drug-device combination products, or respiratory device components.

• Advanced degree is preferred.

🏝️ Benefits

• Eligibility for an annual bonus.

• Long-term incentive eligibility, if applicable.

• Comprehensive medical, dental, and vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays and vacation time.

• Compassionate and sick leave days.

• Flexible remote work arrangements.