Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)
$156,900–$247,000 year
On-siteRahway, New Jersey, United States or West Point, Pennsylvania, United States
Job Summary
Lead inhalation subject-matter expertise across dry powder inhaler, nebulized, and respiratory delivery programs, assessing device-platform options, drug-device compatibility, and aerosol characterization strategies. Direct the device development strategy for multiple combination product programs from concept through clinical and commercial launch, coordinating cross-functional working groups to align device selection, aerosol performance, and patient-use requirements. Serve as technical integrator for engineering design, manufacturing unit operations, and risk management, while managing external engagements with CDMOs, suppliers, and manufacturing partners. Author and review regulatory submissions including INDs, IMPDs, and NDAs, and oversee clinical supplies production and design history file development. Maintain engagement with Early and Product Development Teams, proactively resolve project obstacles, and stay current on worldwide regulations and inhalation delivery technologies to drive innovation.
Required Qualifications
- B.A./B.S in Pharmaceutical, Science, Biomedical or Engineering-related subject
- Minimum of 10 years of combined experience in, (bio)pharmaceutical, medical device and combination product development
- Advanced degree
- 5+ years of leadership experience with deep working knowledge of device, biologic/drug product and process development including regulatory submission and approval processes
- 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
- 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
- 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
Desired Qualifications
- Experience with development of inhalation drug products, inhalation drug-device combination products, or respiratory device components
- Knowledge of regulatory expectations and guidance for orally inhaled and nasal drug products, inhalation combination products, device performance, aerosol characterization, and patient-use considerations
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