Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs

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🔥 9 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $156.9k - $247k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Set tactical and strategic direction for inhalation drug-device combination product programs • Lead inhalation subject-matter activities across dry powder inhalers, nebulized therapies, and other respiratory delivery programs • Lead device development strategies from concept generation and platform assessment through feasibility, development, verification, validation, and launch readiness • Lead cross-functional Device Working Groups integrating clinical, regulatory, formulation, commercial, human factors, quality, and manufacturing activities • Lead Device Development Engineering Core teams defining design requirements and engineering execution • Represent Device Development and Device Working Groups on cross-functional development and commercialization teams • Engage with external inhalation CDMOs, device designers/developers, component suppliers, and manufacturing partners • Oversee technical integration of formulation-device compatibility, device assessment, manufacturing, aerosol performance testing, design controls, risk management, verification, validation, assembly, and human factors activities • Anticipate and resolve technical and project obstacles and communicate challenges, risks, timelines, and milestones • Author and review regulatory submission content for INDs, IMPDs, NDAs, BLAs, and related combination product programs • Lead or support clinical supplies production, device component manufacture, and final assembly • Improve Device Development and Device Project Leader processes, procedures, and tools • Maintain design controls and design history file development, including user needs, design inputs, risk controls, verification evidence, and validation strategy • Monitor inhalation technologies, respiratory platforms, regulations, standards, and industry developments • Enhance the company’s professional image through publications, presentations, patents, and professional activities

🎯 Requirements

• B.A./B.S. in Pharmaceutical, Science, Biomedical, or Engineering-related subject • Minimum 10 years of combined experience in biopharmaceutical, medical device, and combination product development • 5+ years of leadership experience with device, biologic/drug product, and process development, including regulatory submission and approval processes • 5+ years of leadership experience 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 • 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, medical device, and healthcare regulations • Knowledge of FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ISO 11608, ISO 11040, EN 62366, and Council Directive 93/42/EEC • Proven experience applying analytical and technical judgment to inhalation product or manufacturing process design, development, validation, and lifecycle management • Ability to interpret device, aerosol, formulation, and process performance data • Ability to work independently and lead team members with different skill sets and backgrounds • Ability to influence without formal authority and present ideas to senior leadership • Excellent communication, presentation, negotiation, project management, and organizational skills • Experience leading complex development projects at enterprise level • Willingness to travel • Ability to continuously multitask • Experience with inhalation drug products, inhalation drug-device combination products, or respiratory device components strongly preferred • Advanced degree preferred

🏖️ Benefits

• Annual bonus eligibility • Long-term incentive eligibility, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement