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Principal Scientist

Company: Glaukos Corporation
Location: San Clemente
Posted on: September 5, 2020

Job Description:

When you join us at Glaukos, you will be a part of 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-the iStent---in the United States, followed by our next-generation iStent inject-- device in September 2018.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.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 located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.How will you make an impact?The Process Development and Technology Transfer--Principal Scientist, based in San Clemente, CA is responsible for leading the formulation process development and scale up efforts to support Phase 2-3 clinical scale and technology transfer to manufacturing operations for commercial scale up. Responsibilities include qualifying new raw materials (excipients and APls), recommending specifications for products and designing and evaluating product manufacturing processes using quality by design principles for materials and process parameters evaluation and qualification. Leading the formulation optimization and scale up studies based on in-depth understanding of manufacturing processes for solid and semi-solid dosage forms. Serve as a Formulation/CMC Development representative on interdisciplinary and multidisciplinary project teams.--Provide leadership for the CMC/Formulation Development and Technology Transfer sub-teams.What will you do?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.Support the qualification, calibration and maintenance of R&D equipment in accordance with GLP /cGMPs.Ensure compliance with product quality, safety, performance and efficiency.Review and apply the compendia requirements for use of excipients.Design and execute protocols necessary to complete projects.Possess comprehensive knowledge of techniques in areas of solids, liquid and semi-solids dosage forms supporting formulation development and scale.Prepare and review scientific documentation such as, laboratory notebooks, data analysis, regulatory reports, master formulas, manufacturing procedures, product development reports and SOPs.Prepare written reports for regulatory filings and documents all formulation activities pursuant to cGMP standards.Provide leadership to team members on CMC teams.Interface with internal (Quality, Operations, Regulatory) and external business partners (CROs, CMOs) on designing and executing product development project plans.Develop systems that are cost effective and increase efficiency.Maintain and apply current knowledge of cGMP documents and guidance, other FDA/ICH guidance and SOPs.Coordinate with analytical chemists for completing testing of new drug products in a timely manner, and developing appropriate controls.Provide leadership for the CMC/Formulation Development and Technology Transfer sub-teams. Author the CMC product development sections of regulatory documentation--(IND, IMPD, MAA, etc.).How will you get here? EducationGraduate or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or a related science.Requirements------------------8 years of experience in formulating various dosage forms in a pharmaceutical laboratory, including ophthalmic semi-solid dose formulations.Working knowledge of experimental designs and clinical manufacturing, validation. and report writing for regulatory submissions.Knowledge of product lifecycle - Product and process development, clinical trials. validation and regulatory submissions, commercial GMP manufacturing.Demonstrated knowledge of pharmaceutical manufacturing of ophthalmic products, sterilization methods, aseptic processing, and process development.Proficient with interpreting and implementing cGMPs, cGLPs, ICH, USP, FDA, DEA and OSHA guidelines.Independent formulation research on enabling technologies and or unique delivery systems.Excellent interpersonal and verbal/written communication skills that enable effective management and resolution of complex project-related issues involving collaborations with multiple functional areas.Experience participating or leading tech transfers.Excellent presentation and communication skills.Must be able to function and contribute as part of a team. have excellent communication skills and contribute to team based decisions.Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.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're a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than 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.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 paid time off & 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! Check out our profile on The Muse to get an inside look at our company culture. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!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.

Keywords: Glaukos Corporation, San Clemente , Principal Scientist, Other , San Clemente, California

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