Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company’s second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, CA.
The Scientist, based in San Clemente, CA will have primary responsibility is for the design, execution and reporting on in vitro studies supporting the clinical development of multiple drug delivery projects. In addition the scientist may also support other R&D projects in the portfolio by conducting in vitro and bench analytical studies. The position is in CMC /Pharmaceutical Development and is expected to support drug delivery project teams by providing support on projects pertaining to drug delivery/elution rate testing, potency and impurity determination by developing and validating various methods. The scientist is expected to participate in team meetings and interfacing with internal/external scientists from other disciplines. He /she writes technical reports and presents experimental data to project teams and provides recommendations for next steps. The scientist is required to perform experiments in compliance with relevant regulatory expectations including cGLPs and cGMPs.
· Develops analytical methods for potency, elution, and formulation stability analysis. The scientist is expected to design experiments to maximize the information obtained from the studies and quality of data. Also assumes overall responsibility for the technical conduct of studies and assures that all aspects of studies and method validations are performed in accordance with regulations and SOP’s.
· Reviews and approves the interpretation, analysis, documentation and reporting of results of studies to assure accuracy and in accordance with compliance standards.
· Participates in project teams. Provides technical input and plays an integral role in the project functional development plans.
· Communicates with the team leaders and members on a regular basis and promptly notifies functional head and team leaders of issues.
· Collaborates with QC Analytical Laboratory by transferring test method from R&D to cGMP QA Testing Laboratory.
· Scouting, new opportunity evaluation.
· Evaluates available information/literature and provides technical expertise to assess and advice on the safety of new ingredients, compounds, acquisitions and competitor products.
· Minimum of 3 years of experience in Analytical chemistry in pharmaceutical /biotech companies, specifically HPLC and GC analysis of pharmaceutical preparations and/or biological samples for active pharmaceuticals and/or impurities. Regulated GLP, GMP training and experience and method development and trouble-shooting experience are desired.
· Trained in application of HPLC and/or GC assays for pharmaceutical sample analysis
· Understands and creates GLP or GMP documentation
· Attention to detail and ability to organize and present generated data (use of instrument software, Excel, PowerPoint, Word)
· Excellent analytical and communication skills, both verbal and written,
Minimal of B.S. in Chemistry or relevant scientific field with 10+ years of experience, or MS degree with 8+ or Ph.D. with minimally 2 years of relevant industry experience for the Scientist levels and 5 year for the Sr. Scientist level.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.