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