Principal Scientist, Analytical Development

About SpyGlass Pharma:

At SpyGlass Pharma (NASDAQ: SGP), we are focused on improving and preserving the vision of patients living with chronic eye diseases, while minimizing the burden treatment can place on their daily lives. We are advancing innovative long-term ophthalmic drug delivery technologies designed to provide sustained therapy through cataract surgery and help improve patient outcomes.

We have built a highly collaborative team with deep expertise across ophthalmology, drug delivery, pharmaceuticals, and medical devices. Our scientists, engineers, and clinical leaders bring decades of experience developing and commercializing breakthrough technologies, united by a shared commitment to patients and our guiding principle: “We create for patients.” That mindset shapes how we build our products, our teams, and our culture.

Backed by strong clinical progress, significant funding, and a growing organization, SpyGlass Pharma is entering an exciting stage of growth as we advance our lead program, the SpyGlass BIM-IOL, through Phase 3 clinical development.

Summary:

The Principal Scientist, Analytical Development, will lead hands-on method development, validation, and stability studies supporting advanced drug delivery systems. This role requires expertise in advanced analytical techniques, strong problem-solving skills, and a collaborative approach to achieving scientific and organizational goals.

Essential Duties And Responsibilities:

- Lead the hands-on, in-house development, feasibility, validation, and transfer of critical analytical methods and procedures supporting clinical-stage ophthalmic drug delivery platforms.

- Collaborate with cross-functional teams, including formulation development, process development, regulatory affairs, and quality assurance, to ensure alignment with product development goals.

- Design and execute phase-appropriate analytical development plans to deliver high-quality, compliant data from preclinical evaluation through clinical trials and final marketing approval.

- Prepare, review, and approve analytical protocols, reports, and sections of regulatory submissions to ensure accuracy, completeness, and compliance.

- Conduct stability studies for development and GMP batches, ensuring compliance with regulatory requirements and supporting specifications and shelf-life determinations.

- Coordinate with and manage multiple 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 a culture of continuous improvement, collaboration, and scientific excellence within the team.

Qualifications Required For Position:

- PhD in pharmaceutical sciences, analytical chemistry, or a related field with 8+ years of relevant analytical development experience, or MS with 12+ years of experience.

- Experience with method development for analytical attributes (e.g. drug assay, impurities, particulate matter and in-vitro extended drug release testing).

- Expertise in chromatographic techniques (e.g., HPLC, GC), and spectroscopy (e.g., UV-Vis, FTIR, and mass spectrometry).

- Familiarity with methods for particulate matter testing (e.g. light obscuration and microscopy).

- Proficiency in analytical software tools and data analysis platforms (e.g., Empower, ChemStation).

- Strong knowledge of regulatory requirements and industry standards for analytical method validation, including ICH guidelines and USP/EP requirements.

- Demonstrated experience in managing analytical projects, including CRO interactions and alignment with clinical-stage pharmaceutical development.

- Exceptional problem-solving and project management skills, with a proven ability to lead complex analytical initiatives.

- Excellent written and verbal communication skills, capable of conveying technical information effectively to diverse stakeholders.

- Demonstrated ability to work collaboratively in a fast-paced, multidisciplinary team environment.

Why SpyGlass Pharma?

- We are offering a range of $160,000 - $190,000 based on experience and qualifications, along with an Annual Bonus opportunity.

- Share in our success with stock options, giving you a stake in the company’s future.

- Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.

- Generous paid time off, including holidays, vacation days, and personal leave.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.