Director, Analytical Development

Spyglass Pharma•Aliso Viejo, CA

2d•$225,000 - $250,000

About The Position

SpyGlass Pharma is focused on improving and preserving the vision of patients suffering from chronic eye conditions. They aim to develop cutting-edge long-term drug delivery products to address common causes of blindness. The company has a highly collaborative team with deep expertise across ophthalmology, drug delivery, pharmaceuticals, and medical devices. SpyGlass Pharma is entering an exciting stage of growth as they advance their lead program, the SpyGlass BIM-IOL, through Phase 3 clinical development. This role will lead late-stage analytical development activities for their 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.

Requirements

PhD or equivalent degree in analytical chemistry, organic chemistry, biochemistry, chemical engineering, pharmaceutical sciences, or a related field with a minimum of 10 years of experience in small molecule pharmaceutical development.
Expertise in 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 a team, 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.

Nice To Haves

Demonstrated oversight of late-stage analytical development programs with experience supporting regulatory submissions including marketing applications is strongly preferred.

Responsibilities

Define and execute analytical development strategies across the 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 deliver timely and accurate analytical data for all stages of the development lifecycle through commercialization.
Oversee the design and execution of stability programs, and establish scientifically sound retest periods and shelf life.
Direct multiple internal and CRO resources to achieve analytical department objectives effectively.
Provide scientific and technical expertise to troubleshoot analytical challenges, investigate out-of-specification results, and implement corrective and preventive actions, 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.