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.
