Principal Scientist, Nasal Sprays Job Listing at Kelly Services in South San Francisco, CA (Job ID US3631695_BH10046018)

Description

Kelly® Science & Clinical is seeking a Principal Scientist for a remote direct hire opportunity with one of our clients, a neuroscience-focused biotechnology company in South San Francisco, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Workplace: Remote (US)
Pay: 140,000-170,000/year
Position title: Principal Scientist, Nasal Sprays
Position type: Direct hire
A leading biotechnology organization is seeking a highly experienced and motivated Principal Scientist specializing in Drug Product & Analytical Development. This strategic role will drive late-stage clinical and commercial manufacturing activities, analytical method development, and validation for intranasal drug products. The successful candidate will be responsible for optimizing, developing, and validating analytical methods specific to nasal spray products, managing outsourced manufacturing and analytical activities with contract partners, and serving as the drug product/analytical lead across all CMC (Chemistry, Manufacturing, and Controls) teams. Additionally, this position will provide technical expertise across multiple development programs, monitor industry advancements, and oversee the manufacture of registration batches. This is a full-time opportunity, available remotely from any location within the continental United States, reporting directly to the Senior Vice President, Head of CMC.
Responsibilities

• 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.

Qualifications

• Master's degree in Process Engineering, Pharmaceutical Sciences, or a related discipline, with 8–10 years of experience in pharmaceutical or biotechnology industry (direct sponsor experience preferred); or Ph.D. in a relevant scientific field with 5–8 years of experience in pharmaceutical or biotechnology industry (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.

What happens next?
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

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