Principal Scientist, Mixed Modality Product Development - Inhalation
Merck
4 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Principal Scientist (Inhalation Products)
Primary Duties
- Lead the design and development of integrated (single-entity) and non-integrated (co-packaged/cross-labelled) inhalation products (e.g., DPIs, MDIs, nebulizers, nasal sprays).
- Act as a seasoned inhalation formulation scientist; provide strategic and technical leadership to drive program milestones.
- Support early and late-stage candidates: formulation and composition, combination product development, scalable process, primary packaging, compatibility characterization, and regulatory filings.
- Collaborate across Research and Manufacturing to drive capability evaluations/builds and align with organizational goals.
- Build collaborations across internal functions and external academic/regulatory communities.
- Mentor and/or supervise a small group of scientists.
Minimum Education Requirements
- Ph.D. with 8+ years industry experience; M.S. with 10+ years; or B.S. with 14+ years in Chemical/Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry/Sciences, Chemistry/Biochemistry or related.
Required Experience and Skills
- Deep expertise in inhalation dosage forms (DPI, MDI, soft-mist, nebulized): formulation, device interaction, performance drivers.
- Pulmonary formulation development: particle engineering, aerosol optimization, dispersion, and stability of respirable particles.
- Hands-on aerosol characterization (NGI/ACI cascade impactors, APSD, laser diffraction, NGI operation/data interpretation).
- Device/formulation compatibility testing; dose delivery metrics and device performance troubleshooting.
- Inhalation PK and lung deposition; IVIVC and translation to clinical outcomes.
- Regulatory/dossier preparation for inhalation products (ICH, FDA, EMA; CMC for NDAs/BLAs/MAAs).
- Manufacturing/scale-up, technology transfer, and GMP considerations for device assembly and aseptic/non-aseptic steps.
- QbD and DOE to inform risk; lead cross-functional teams and technology selection/builds.
- Strong communication and collaboration; mentorship track record.
Preferred Experience and Skills
- Modeling/simulation for aerosol deposition/PK (e.g., CFD, PBPK).
- Influence regulatory strategy and support global filings; biologic/large-molecule inhalation experience is a plus.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).
Primary Duties
- Lead the design and development of integrated (single-entity) and non-integrated (co-packaged/cross-labelled) inhalation products (e.g., DPIs, MDIs, nebulizers, nasal sprays).
- Act as a seasoned inhalation formulation scientist; provide strategic and technical leadership to drive program milestones.
- Support early and late-stage candidates: formulation and composition, combination product development, scalable process, primary packaging, compatibility characterization, and regulatory filings.
- Collaborate across Research and Manufacturing to drive capability evaluations/builds and align with organizational goals.
- Build collaborations across internal functions and external academic/regulatory communities.
- Mentor and/or supervise a small group of scientists.
Minimum Education Requirements
- Ph.D. with 8+ years industry experience; M.S. with 10+ years; or B.S. with 14+ years in Chemical/Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry/Sciences, Chemistry/Biochemistry or related.
Required Experience and Skills
- Deep expertise in inhalation dosage forms (DPI, MDI, soft-mist, nebulized): formulation, device interaction, performance drivers.
- Pulmonary formulation development: particle engineering, aerosol optimization, dispersion, and stability of respirable particles.
- Hands-on aerosol characterization (NGI/ACI cascade impactors, APSD, laser diffraction, NGI operation/data interpretation).
- Device/formulation compatibility testing; dose delivery metrics and device performance troubleshooting.
- Inhalation PK and lung deposition; IVIVC and translation to clinical outcomes.
- Regulatory/dossier preparation for inhalation products (ICH, FDA, EMA; CMC for NDAs/BLAs/MAAs).
- Manufacturing/scale-up, technology transfer, and GMP considerations for device assembly and aseptic/non-aseptic steps.
- QbD and DOE to inform risk; lead cross-functional teams and technology selection/builds.
- Strong communication and collaboration; mentorship track record.
Preferred Experience and Skills
- Modeling/simulation for aerosol deposition/PK (e.g., CFD, PBPK).
- Influence regulatory strategy and support global filings; biologic/large-molecule inhalation experience is a plus.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).