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Associate Director of Analytical R&D

Spyglass Pharma

Spyglass Pharma

Aliso Viejo, CA, USA · Aliso Viejo, CA, USA · United States
Posted on Monday, May 27, 2024

About SpyGlass Pharma:

At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.

Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.

Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com

Summary:

The Associate Director of Analytical Development will play a key role in leading the development, validation, and transfer of analytical methods for ophthalmic drug delivery systems. Collaborating with various teams, they will design analytical development plans, manage stability programs, and ensure regulatory compliance.

Essential Duties & Responsibilities:

  • 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, 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 preclinical and clinical stages of drug development.
  • Oversee the design and execution of stability programs for development and GMP batches, establishing scientifically sound shelf life supported by stability data.
  • Manage and direct multiple 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 pharmaceutical sciences, chemistry, biochemistry, or a related field with a minimum of 8 years of experience in small molecule analytical development within a pharmaceutical company or CRO.
  • Bachelor’s or equivalent degree in pharmaceutical sciences, chemistry, biochemistry, or related field with a minimum of 12 years of experience in small molecule analytical development within a pharmaceutical company or CRO.
  • 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.
  • 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.
  • Experience with late-stage regulatory submissions and interactions with regulatory agencies (FDA, EMA, etc.) is preferred.
  • Proficiency in analytical software and data analysis tools (e.g., Empower, ChemStation, Minitab) is desirable.

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.