Executive Director Analytical Development Cmc Jobs

About SpyGlass Pharma:

At SpyGlass Pharma (NASDAQ: SGP), we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

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:

We are seeking a Director of Analytical Development to join our team at SpyGlass Pharma. This role will lead late-stage analytical development activities for our lead program as it advances through Phase 3 clinical development toward submission.

The Director will provide technical and strategic leadership for analytical method development, qualification, validation, stability, and technology transfer activities required to support late-stage clinical development, regulatory submissions, and commercial readiness. This individual will work closely with cross-functional teams including pharmaceutical development, manufacturing, quality, regulatory affairs, and external development partners to ensure robust analytical support throughout product development and commercialization.

This role will also lead and mentor a team of analytical scientists responsible for method development, characterization, stability, and testing activities, while playing a key role in developing the overall analytical and CMC strategy to support NDA submission, future commercial manufacturing, and lifecycle management initiatives.

Essential Duties & Responsibilities:

• Define andexecute analyticaldevelopmentstrategiesacrossthe organizations pipeline.

• Lead and manage a team of scientists and analysts in developing,validating, and transferring analytical methods for clinical-stage ophthalmic drug delivery systems.

• Collaborate closely with cross-functional teams, including formulation development, process development,engineering, tech ops,regulatory affairs, and quality assurance, to support product development programs.

• Design and execute comprehensive analytical development plans to delivertimelyandaccurateanalytical data forall stages of the development lifecycle throughcommercialization.

• Oversee the design and execution of stabilityprograms,andestablishscientifically soundretest periods andshelflife.

• Direct multipleinternaland CROresources to achieve analytical departmentobjectiveseffectively.

• Provide scientific and technicalexpertiseto troubleshoot analytical challenges, investigate out-of-specification results, and implement corrective and preventiveactions,as necessary.

• Review and approve analytical protocols, reports, and regulatory submissions to ensure accuracy, completeness, and compliance with regulatory requirements.

• Foster a culture of continuous improvement, collaboration, and excellence within the analytical development team.

Qualifications Required For Position:

• PhD or equivalent degree inanalyticalchemistry,organic chemistry,biochemistry,chemicalengineering, pharmaceuticalsciences,or a related field with a minimum of10years of experience in small molecule pharmaceuticaldevelopment.

• Expertisein a wide range of analytical techniques, including chromatography, spectroscopy, mass spectrometry, and physicochemical characterization methods.

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

• Profound working knowledge of cGMP requirements.

• Proven ability to lead and mentor ateam, fostering a collaborative and high-performance work environment.

• Excellent communication and interpersonal skills, with the ability to effectively communicate complex scientific concepts to diverse stakeholders.

• Demonstratedoversight oflate-stageanalytical development programswithexperience supportingregulatory submissionsincludingmarketing applications isstronglypreferred.

Why SpyGlass Pharma?

• We are offering a range of $225,000 - $250,000, 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 JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.