Principal Scientist, Analytical Development

Spyglass Pharma•Irvine, CA

About The Position

The Principal Scientist, Analytical Development, will lead hands-on analytical method development, validation, transfer, and stability studies supporting clinical-stage ophthalmic drug delivery platforms. The role develops and executes phase-appropriate analytical plans and produces high-quality, compliant data from preclinical evaluation through clinical trials and marketing approval. It also includes preparing and reviewing analytical documentation and regulatory submission sections, coordinating contract research organization (CRO) resources, and addressing analytical challenges and out-of-specification results. The scientist collaborates with formulation development, process development, regulatory affairs, and quality assurance teams, and contributes to continuous improvement and scientific excellence. SpyGlass Pharma is developing long-term ophthalmic drug delivery technologies intended to provide sustained therapy through cataract surgery. Its lead program, the SpyGlass BIM-IOL, is in Phase 3 clinical development. The company describes its culture as collaborative and guided by the principle “We create for patients.”

Requirements

PhD in pharmaceutical sciences, analytical chemistry, or a related field and 8+ years of relevant analytical development experience, or an MS and 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, including the ability to lead complex analytical initiatives.
Excellent written and verbal communication skills and the ability to convey technical information to diverse stakeholders.
Ability to work collaboratively in a fast-paced, multidisciplinary team environment.

Responsibilities

Lead hands-on 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 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 while meeting regulatory requirements.
Coordinate and manage multiple CRO resources to achieve analytical objectives.
Review raw data records, integration parameters, calculations, and results against 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.