Principal Scientist, Nasal Spray and Inhalation Drug Products

Principal Scientist, Nasal Spray and Inhalation Drug Products

Principal Scientist specializing in Drug Product & Analytical Development, responsible for optimizing, developing, and validating analytical methods specific to nasal spray products and overseeing late‑stage clinical and commercial manufacturing activities.

Location:

Remote (United States). Job type:
Direct hire, full‑time. Pay: $160,000 - $190,000 per year.

Company:
Neuroscience‑focused biotechnology organization. Reporting directly to the Senior Vice President, Head of CMC.

• Provide strategic leadership for drug product development and analytical activities, ensuring alignment with program objectives and timelines.
• Serve as the analytical and drug product representative on CMC teams, facilitating cross‑functional collaboration and execution.
• Lead departmental and cross‑functional initiatives, contributing to strategic planning and technical direction.
• Oversee timely achievement of critical milestones in nasal spray drug product development, including process development, technology transfer, cGMP manufacturing, stability studies, process characterization (QbD), and validation.
• Manage production of registration batches in accordance with regulatory guidelines and quality standards.
• Coordinate with contract manufacturing and research organizations (CMOs, CROs), supporting technical onboarding, transfer, and ongoing oversight of outsourced activities.
• Lead method development and validation for nasal spray‑specific analytical techniques, as well as general chromatographic methods.
• Ensure analytical testing is conducted in full compliance with regulatory (ICH, FDA) and internal quality requirements.
• Provide technical oversight for CRO activities, ensuring successful method transfer and operational implementation.
• Act as a technical resource for strategic decision‑making, risk assessment, and mitigation strategies.
• Track industry developments and incorporate innovative methodologies into nasal spray drug product development and analysis.
• Support multiple programs by providing technical expertise and promoting cross‑functional teamwork.
• Author and review technical documentation, including protocols, reports, analytical methods, SOPs, and regulatory submission materials.
• Maintain compliance with GMP and regulatory standards across development and manufacturing stages.

• Master’s degree in Process Engineering, Pharmaceutical Sciences, or related field with 8–10 years of experience in the pharmaceutical or biotechnology industry (direct sponsor experience preferred); or Ph.D. in a relevant scientific field with 5–8 years of experience (direct sponsor experience preferred).
• Hands‑on expertise with nasal spray and/or inhalation product analytical technologies (e.g., Particle Size Analysis, Plume Geometry, Spray Pattern, Droplet Size Distribution, Actuation Force) and chromatographic tools (e.g., HPLC‑UV, LC‑MS).
• Comprehensive knowledge of ICH, FDA, and related regulatory requirements for method validation, method transfer, GMP manufacturing, and analytical testing.
• Advanced proficiency in literature search strategies for troubleshooting nasal spray and/or inhalation product development challenges.
• Demonstrated experience in CMC GMP pharmaceutical development, including successful process scale‑up and validation.
• Substantial experience in outsourcing and managing projects with CROs and CMOs.
• Advanced skills in Microsoft Word, Excel, and PowerPoint; familiarity with statistical analysis tools (e.g., JMP, Prism).
• Creative, self‑directed problem‑solving abilities in a multidisciplinary setting, with demonstrated accountability for functional or departmental strategy.

Once you apply, you’ll proceed to the next steps if your skills and experience match our requirements. Even if this position doesn’t work out, you’ll remain in our network for future opportunities.

Mid‑Senior level

Full‑time

Research and Science

Pharmaceutical Manufacturing and Biotechnology Research