Sr. Scientist II, R&D

<p class="">Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.<br /><br /></p>

Aliso Viejo, CA


<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases.</h4>

keywords: position summary,compensation,analysis,support,communication,performance,education & experience,knowledge,skills

Full time

Base Salary Range: $109,100 - $141,800

Overview: <p><strong>Glaukos is Growing!</strong></p> <p><strong>GLAUKOS #DareToDomore&nbsp;&nbsp;<u>Sr. Scientist II&nbsp;- Aliso Viejo, CA</u></strong></p> <p>We are a medical technology and pharmaceutical company that&rsquo;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&reg; W), corneal disorders and retinal diseases.</p> <p>We are looking for a Sr. Scientist II to join our team. We have an amazing culture that fosters opportunities for growth, excellent benefits, great pay, a hybrid work model, and are Great Place to Work Certified.&nbsp;</p> <p><strong>How Will You Make An Impact?</strong></p> <p>This position will focus on development, validation, and transfer of analytical methods for drug products and drug substances as well as oversight of stability studies and trending analysis.&nbsp;The position will establish, coordinate, and monitor analytical related activities internally as well as CROs and CMOs to ensure quality and timeliness of projects. It works effectively and collaboratively with cross-functional groups and may represent as analytical supervisor on CMC project teams.&nbsp;This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.</p>
Responsibilities: <ul> <li>Provides technical expertise to design, conduct, and implement analytical development activities to support all stages of drug development. Evaluates and interprets analytical results from release and stability studies and provides scientific conclusions.</li> <li>Hands-on and direct expertise in analytical methodologies used for the characterization of drug delivery systems and protein formulations for drug release, potency, biological activity, stability, impurity testing and aggregation profile.</li> <li>Prepares high quality experimental protocols and technical reports in support of regulatory submissions. authors appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions.&nbsp;</li> <li>Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting company goals and participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas.&nbsp;</li> <li>Represents as analytical guide on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robust methods, product specifications, method validations and method transfers.&nbsp;</li> <li>Proactively develops and maintains knowledge in current analytical sciences and investigates new technology, recommends and implements innovative techniques to the team.</li> </ul>
Requirements: <ul> <li>Ph.D. (with 5+ years) or M.S. (8+ years) in analytical chemistry, pharmaceutical chemistry, pharmaceutical sciences, or related scientific field.</li> <li>6+ years of pharmaceutical industry experience in analytical method development, testing of drug products and regulatory submissions.</li> <li>Hands-on knowledge of chromatographic theory and technology.</li> <li>Knowledge of HPLC, UPLC, GC, Dissolution, LC-MS, UV/Vis, and other common analytical techniques.</li> <li>Investigates and troubleshoots analytical related problems at all stages of development.</li> <li>Develop, validate and transfer analytical methods.&nbsp;Experience in oversight of stability studies, conducting trend analysis and interpreting data.&nbsp;</li> <li>Interact with pharmaceutical CROs and CMOs.&nbsp;</li> <li>Project management skills. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.&nbsp;</li> <li>Knowledge of drug development and product regulations.</li> </ul> <br /><br /> <p><strong>Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.</strong>&nbsp;&nbsp;</p> <p>These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.&nbsp;</p> <p>Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.&nbsp;</p> <p>We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off &amp; paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Glaukos Corporation has been Certified as a Great Place to Work the last two years!&nbsp;</p> <p>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.&nbsp;</p>