Glaukos is a medical technology and pharmaceutical company that’s advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market-leader iStent inject® W), corneal disorders and retinal diseases.

Glaukos is looking for a motivated bioanalytical scientist to join the Pharmacokinetics, Drug Disposition, and Clinical Pharmacology team. This team develops and executes the nonclinical and clinical ADME strategy for our novel pharmaceutical products. The team is also responsible for developing and performing liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays to assess local biodistribution, systemic exposure, and quantitation of small molecules and metabolites in biological fluids and tissues.

A successful candidate will contribute to internal method development and quantitation efforts and will manage external activities at CROs to provide timely bioanalytical support for Research and Development project teams. This candidate will demonstrate excellent collaboration and communication skills while serving as a subject matter expert advising colleagues from the Applied Research and Translational Sciences group (and other relevant departments) how LC-MS/MS techniques may address key project questions. The ideal candidate would be versatile, self-motivated, timeline and process oriented and demonstrate independent method development skills and the ability to troubleshoot.

What will you do?

• Perform hands on LC-MS/MS method development, method optimization, fit-for-purpose qualification and non-regulated (non-GLP) bioanalytical sample analysis in a variety of biological fluids and tissues in a timely manner
• Coordinate with and monitor external CROs on method development, qualification, validation and sample analysis to enable PK/PD, GLP Tox, and clinical PK studies
• Write formal study reports and bioanalytical sections of regulatory documents for submission to regulatory agencies.
• Maintain awareness and identify state-of-the-art technologies and methodologies that enhance the department’s ability to answer key research and development questions
• Maintain state-of-the-art lab equipment (e.g. LC-MS/MS instruments)
• Closely collaborate with colleagues in the non-clinical development organization and other relevant departments

How will you get here?

• Bachelor’s degree in chemistry or a closely related discipline, and a minimum of 5-8 years related experience, or Master’s degree and 2-5 years of experience, or PhD and 0-4 years of experience
• Hands-on experience with development and non-regulated (non-GLP) qualification of LC-MS bioanalytical methods for small molecule drugs and peptides using various techniques (LLE, SPE and immunoprecipitation) in biological fluids and tissues
• Familiarity with GLP regulations and bioanalysis-associated FDA and ICH guidances
• Experience in collaborating with and monitoring CRO method development, validation, and sample analysis (both non-GLP and GLP) activities to ensure timely delivery of data to project teams
• Strong verbal and written communication skills.
• Strong organizational skills and keen attention to detail; ability to handle multiple projects in a fast-paced environment
• Proven ability to work independently and to collaborate cross-functionally to accomplish goals in a timely manner

Preferred Experience:

• Familiarity with Sciex LC-MS/MS systems and software.
• Additional knowledge of ligand binding assays (e.g. ELISA) is helpful
• Basic understanding of pharmacokinetics and drug metabolism is helpful.