Senior Analytical Scientist - Ophthalmic Drug Delivery

SpyGlass Pharma, Inc.; Irvine (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Stock options

Annual bonus opportunity

Comprehensive health, dental, and VIs

Generous paid time off

Job summary

SpyGlass Pharma is seeking a Principal Scientist, Analytical Development, to lead hands-on method development, validation, and stability studies for advanced ophthalmic delivery systems. The role demands expertise in chromatographic techniques, spectroscopy, and regulatory standards, with a strong collaborative, problem-solving mindset.

You will coordinate cross-functional teams across formulation, regulatory affairs, and QA, ensuring data quality from preclinical through clinical stages and

Qualifications

• PhD in pharmaceutical sciences, analytical chemistry, or related field with 8+ years of analytical development experience, or MS with 12+ years of experience.
• Experience with method development for analytical attributes (drug assay, impurities, particulate matter and in-vitro extended drug release testing).
• Expertise in chromatographic techniques (HPLC, GC) and spectroscopy (UV-Vis, FTIR, MS).
• Familiarity with particulate matter testing methods (light obscuration, microscopy).
• Proficiency in analytical software tools (Empower, ChemStation).
• Strong knowledge of regulatory requirements and ICH/USP/EP guidelines for method validation.
• Demonstrated experience managing analytical projects including CRO interactions.
• Excellent problem-solving, project management, and communication skills.

Responsibilities

• Lead hands-on in-house development, feasibility, validation, and transfer of analytical methods for clinical-stage ophthalmic platforms.
• Collaborate with formulation, process development, regulatory affairs, and QA to align with product goals.
• Design phase-appropriate development plans delivering compliant data from preclinical to clinical stages.
• Prepare and review analytical protocols, reports, and regulatory submission sections.
• Conduct stability studies for development and GMP batches and determine shelf-life.
• Coordinate with CROs to meet analytical objectives and timelines.
• Review data, calculations, and results against acceptance criteria and troubleshoot issues.
• Drive continuous improvement and scientific excellence within the team.

Skills

Analytical method development

Analytical data analysis

Regulatory knowledge

CRO management

Cross-functional collaboration

Communication

Leadership

Education

PhD in pharmaceutical sciences or analytical chemistry (8+ years)

MS in relevant field with 12+ years

Tools

HPLC

GC

UV-Vis

FTIR

Mass spectrometry

Empower

ChemStation

Job description

SpyGlass Pharma is seeking a Principal Scientist, Analytical Development, to lead hands-on method development, validation, and stability studies for advanced ophthalmic delivery systems. The role demands expertise in chromatographic techniques, spectroscopy, and regulatory standards, with a strong collaborative, problem-solving mindset.

You will coordinate cross-functional teams across formulation, regulatory affairs, and QA, ensuring data quality from preclinical through clinical stages and