Principal Scientist, Analytical Development

Spyglass Pharma • Irvine, CA

1d • $160,000 - $190,000

About The Position

The Principal Scientist, Analytical Development, leads hands-on analytical method development, feasibility, validation, transfer, and stability studies for clinical-stage ophthalmic drug delivery platforms. The role develops and executes phase-appropriate analytical plans and delivers high-quality, compliant data from preclinical evaluation through clinical trials and marketing approval. It works closely with formulation development, process development, regulatory affairs, quality assurance, and CRO resources, and contributes to regulatory submissions, troubleshooting, and continuous improvement.

Requirements

• PhD in pharmaceutical sciences, analytical chemistry, or a related field with 8+ years of relevant analytical development experience, or an MS with 12+ years of experience.
• Experience developing methods for analytical attributes such as drug assay, impurities, particulate matter, and in-vitro extended drug release testing.
• Expertise in chromatographic techniques such as HPLC and GC, and spectroscopy such as UV-Vis, FTIR, and mass spectrometry.
• Familiarity with particulate matter testing methods such as light obscuration and microscopy.
• Proficiency with analytical software and data analysis platforms such as Empower and ChemStation.
• Strong knowledge of regulatory requirements and industry standards for analytical method validation, including ICH guidelines and USP/EP requirements.
• Demonstrated experience managing analytical projects, including CRO interactions and alignment with clinical-stage pharmaceutical development.
• Strong problem-solving and project management skills, with demonstrated ability to lead complex analytical initiatives.
• Excellent written and verbal communication skills, including the ability to convey technical information to diverse stakeholders.
• Ability to work collaboratively in a fast-paced, multidisciplinary team environment.

Responsibilities

• Lead in-house development, feasibility assessment, validation, and transfer of analytical methods and procedures supporting clinical-stage ophthalmic drug delivery platforms.
• Collaborate with formulation development, process development, regulatory affairs, and quality assurance teams to align analytical work with product development goals.
• Design and execute phase-appropriate analytical development plans that deliver high-quality, compliant data from preclinical evaluation through clinical trials and marketing approval.
• Prepare, review, and approve analytical protocols, reports, and regulatory submission sections.
• Conduct stability studies for development and GMP batches, supporting specifications and shelf-life determinations in compliance with regulatory requirements.
• Coordinate and manage CRO resources to achieve analytical objectives.
• Review raw data records, integration parameters, calculations, and results against pre-established acceptance criteria.
• Troubleshoot analytical challenges, investigate out-of-specification results, and implement corrective and preventive actions as needed.
• Contribute to continuous improvement, collaboration, and scientific excellence within the team.

Benefits

• Annual bonus opportunity.
• Stock options.
• Health, dental, and vision insurance with a variety of plan and coverage options.
• Paid time off, including holidays, vacation days, and personal leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree