Sr. Scientist II

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.