Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)
Merck
August 06, 2026
Remote
United States
Operations
Principal Responsibilities:
- Provide inhalation subject-matter leadership for dry powder inhalers, nebulized and other respiratory delivery programs (device-platform options, drug-device compatibility, dose delivery, aerosol strategy/characterization, usability, clinical supply readiness, transition to commercial manufacturing).
- Lead device development strategy for inhalation drug-device combination product programs from concept through feasibility, development, verification/validation, and clinical/commercial launch readiness.
- Lead cross-functional Device Working Groups and Device Development Engineering Core teams to integrate device development with clinical, regulatory, formulation, commercial, human factors, quality, and manufacturing.
- Coordinate device-platform selection, drug-device interface definition, aerosol performance strategy, and patient-centric usability.
- Serve as technical integrator across CDMO/site selection, compatibility, unit operations/design controls, risk management, inhalation test method development, verification/validation, assembly/container closure/device interfaces, and human factors.
- Author/review regulatory submission content relevant to device description, design controls, risk management, human factors, aerosol performance, manufacturing process, and control strategy.
Qualifications (Requirements):
- B.A./B.S. in Pharmaceutical/Science/Biomedical/Engineering + 10+ years combined (bio)pharma, medical device, combination product development (advanced degree preferred).
- 5+ years leadership in device and biologic/drug product & process development including regulatory submissions/approvals; inhalation/respiratory device or components strongly preferred.
- 5+ years leading complex device/combination programs and cross-disciplinary teams.
- Strong knowledge of design controls, risk management, inhalation device/aerosol performance verification/validation, automation/process development, human factors, and control strategy.
- Knowledge of US/global regulations (e.g., FDA cGMP/QSR, FDA Human Factors, ISO 14971, ISO 11608/11040, EN 62366, EU 93/42/EEC).
Required/Preferred Skills:
- Aerosol, Pulmonary drug delivery, Device development, Dry powder inhalers (DPI), Medical device quality systems, Design controls, Product risk management, Human factors engineering, Manufacturing/process development.
Application instructions:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
Compensation/benefits (if applicable):
- Salary range: $156,900–$247,000; annual bonus and long-term incentive (if applicable); comprehensive benefits package; retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
- Provide inhalation subject-matter leadership for dry powder inhalers, nebulized and other respiratory delivery programs (device-platform options, drug-device compatibility, dose delivery, aerosol strategy/characterization, usability, clinical supply readiness, transition to commercial manufacturing).
- Lead device development strategy for inhalation drug-device combination product programs from concept through feasibility, development, verification/validation, and clinical/commercial launch readiness.
- Lead cross-functional Device Working Groups and Device Development Engineering Core teams to integrate device development with clinical, regulatory, formulation, commercial, human factors, quality, and manufacturing.
- Coordinate device-platform selection, drug-device interface definition, aerosol performance strategy, and patient-centric usability.
- Serve as technical integrator across CDMO/site selection, compatibility, unit operations/design controls, risk management, inhalation test method development, verification/validation, assembly/container closure/device interfaces, and human factors.
- Author/review regulatory submission content relevant to device description, design controls, risk management, human factors, aerosol performance, manufacturing process, and control strategy.
Qualifications (Requirements):
- B.A./B.S. in Pharmaceutical/Science/Biomedical/Engineering + 10+ years combined (bio)pharma, medical device, combination product development (advanced degree preferred).
- 5+ years leadership in device and biologic/drug product & process development including regulatory submissions/approvals; inhalation/respiratory device or components strongly preferred.
- 5+ years leading complex device/combination programs and cross-disciplinary teams.
- Strong knowledge of design controls, risk management, inhalation device/aerosol performance verification/validation, automation/process development, human factors, and control strategy.
- Knowledge of US/global regulations (e.g., FDA cGMP/QSR, FDA Human Factors, ISO 14971, ISO 11608/11040, EN 62366, EU 93/42/EEC).
Required/Preferred Skills:
- Aerosol, Pulmonary drug delivery, Device development, Dry powder inhalers (DPI), Medical device quality systems, Design controls, Product risk management, Human factors engineering, Manufacturing/process development.
Application instructions:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).
Compensation/benefits (if applicable):
- Salary range: $156,900–$247,000; annual bonus and long-term incentive (if applicable); comprehensive benefits package; retirement (401(k)), paid holidays, vacation, and sick/compassionate days.