Scientist - Analytical R&D

How You'll Contribute:

This position is within the Analytical Technologies of the Applied Research department working on implementing and managing analytical activities to support new product development, formulations, early-stage and late-stage clinical studies.

The position will focus on development, validation, and transfer of analytical methods for drug product and drug substance as well as performing analytical testing for release and stability studies, evaluating data and conducting trending analysis. The position will work effectively and collaboratively with cross-functional groups and 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.

What You'll Do:

• Utilizes a strong scientific background to develop and validate methods in an analytical laboratory under supervision
• Operates, maintains and troubleshoots analytical equipment such as HPLC/UPLC, FTIR, UV-Vis Spectrophotometer etc. while ensuring compliance to GLP/GMP standards.
• Troubleshoots and provides analytical support for investigations studies and solves analytical issues in timely manner, ensures generation of high-quality scientific data. Evaluates and interprets analytical results from release and stability studies and provides scientific conclusions.
• Performs bench-level drug product stability testing and release of test articles, generating accurate and precise data using advanced analytical technologies.
• Has hands-on and direct expertise in analytical methodologies used for the drug release, potency, stability, and impurity testing. Demonstrate method suitability for applications to drug product development.
• Prepares experimental protocols and well written technical reports in support of regulatory submissions.
• Proactively develops and maintains knowledge in current analytical sciences and investigates new technology and recommends innovative techniques to the team. Maintain strong working knowledge of ISO/GLP/GMP compliance.
• Plus, other duties as assigned by management

How You'll Get There:

• Strong scientific background and hands-on knowledge of chemical analysis principles, chromatographic theories and technologies.
• Working knowledge of a wide range of analytical methods (i.e., HPLC, UPLC, GC, dissolution, LC-MS, UV/Vis), and other common analytical techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product.
• Ability to troubleshoot analytical related problems at all stages of development.
• Experience in oversight of stability studies and conducting trend analysis.
• Experience working in a cGMP analytical laboratory is preferred.
• Demonstrated ability to learn (new technologies, methodologies etc.)
• Strong ability and knowledge to develop, validate and transfer analytical methods.
• Excellent verbal communication, strong writing skills, and being detail and result oriented are important attributes.
• Working knowledge of drug development and drug substance and drug product regulations, including relevant USP, FDA and ICH regulatory requirements and guidance documents for analytical testing and stability assessments.
• Requires a Bachelor's degree in a Scientific discipline, such as analytical chemistry, pharmaceutical chemistry or pharmaceutical sciences and a minimum of 2-5 years related experience, or a Master's degree and a minimum of 1-2 years of pharmaceutical industry experience

#GKOSUS

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

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.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.