Sr. Scientist II presso Glaukos Corporation
Glaukos Corporation · Aliso Viejo, Stati Uniti d'America · Onsite
- Professional
- Ufficio in Aliso Viejo
Job Title: Senior Scientist II, R&D
Employer: Glaukos Corporation
Location: One Glaukos Way, Aliso Viejo, CA 92656
Hours/Salary: Full-time 40 hours per week/ $140,000 - $147,000 per year
Job Duties:
Manage and oversee qualitative and quantitative chemical analytical activities of drug substance and drug product development for assets, from non-clinical phase to late phase clinical development of intra-ocular drug delivery and/or glaucoma devices and inserters. Serve as technical lead in the analytical team, providing advanced qualitative and quantitative chemical expertise and support for Applied Research projects in various stages of development, and serve as subject matter expert (SME) in project discussions involving product life cycle from development to filing for approval, and post approval changes. Job duties are as follows:
- API (Active Pharmaceutical Ingredient) FORMULTAIONS: Analyze and characterize formulations for suitability in implant models. Design and oversee the execution of experiments leading to the development of rational, scientifically sound formulations and manufacturing processes to support the development of sterile ophthalmic dosage forms. Evaluate relevant characteristics of raw materials and experimental batches in an effort to develop robust manufacturing practices. Ensure compliance with product quality, safety, performance and efficiency.
- DRUG ASSAYS: Develop and conduct assay methods to quantify drug concentration in solutions by HPLC [High-performance liquid chromatography]. Troubleshoot, provide analytical support for investigative studies and solve analytical issues in timely manner, ensuring generation of high-quality scientific data. Review analytical methodologies used for the characterization of drug presence, amount, or functional activity.
- GMP (Good Manufacturing Practices) MANUFACTURING: Participate in GMP builds of product for in vivo studies. Design technology transfer plans and oversee and manage the operations of product transfer from development site to commercial manufacturing site. Manage and collaborate with CMOs and CDMOs for drug substance and drug product development and manufacturing activities at various phases of asset development. Identify critical areas and conduct mini unit operations to gather process understanding during scale up and product transfers. Author, review and approve development protocols and reports, as well as author procedures for cGMP manufacturing operations.
- API STABILITY STUDIES: Perform API Stability Studies to characterize stability of API's by potency, purity, and impurity methods. Participate in bench-level drug product stability testing and release of test articles, generating accurate and precise data using advanced analytical technologies. Troubleshoot and provide analytical support for investigative studies and solve analytical issues, ensuring generation of high-quality scientific data. Evaluate and interpret analytical results from release and stability studies and provide scientific conclusions.
- SUPPORT AND GUIDE JUNIOR STAFF: Provide support and guidance to junior team members in various aspects of analytical development, regulatory agency guidance and professional growth and contribute to the overall scientific skill development in the team.
Job Requirements:
1. Master’s degree in Chemistry, Chemical Engineering, or related discipline, plus 3 years of experience as a Scientist/Sr. Scientist, Analytical R&D or related bench-chemist job in analytical Research and Development.
2. Must include 3 years of experience with the following:
- Ophthalmic medical device or pharmaceutical research and development.
- Analytical method development and validation, including HPLC.
- Collaborating/coordinating with CMOs/CROs/CDMOs.
- FDA & ICH guidelines and cGMP/cGLP procedures.
- Training junior scientists/chemists.
Company
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.
