Senior Pharmaceutical Engineer for Clinical and Commercial Manufacturing

7 days ago


San Clemente, California, United States Glaukos Corporation Full time
About the Role

We are seeking a highly experienced Senior Pharmaceutical Engineer to join our team in San Clemente, CA. As a key member of our manufacturing department, you will be responsible for developing and implementing clinical and commercial manufacturing processes for pharmaceutical products.

Key Responsibilities
  • Develop and implement development/pilot, clinical, and commercial manufacturing processes for pharmaceutical products
  • Support in-house manufacturing and contract manufacturing (CMOs) for development/pilot, clinical, and commercial campaigns
  • Partner with R&D, CMC, QA, and Regulatory on development/study protocols, execution, and reports, equipment and facility qualification, technology transfer, and documentation authoring
  • Manufacture development, pilot, clinical, verification/validation, stability study campaigns, and commercial production
  • Troubleshoot process and equipment issues and perform investigations
Requirements
  • Bachelor's degree in Engineering or Science with 5-8 years direct clinical and/or commercial GMP experience within a pharmaceutical or biotechnology environment
  • Experience in clean room GMP/GLP environments (ISO 5-ISO 8)
  • Strong combination of technical, business, and project management skills
  • Ability to develop robust manufacturing processes that meet Corporate/Operations objectives for cost, quality, manufacturability, vendor quality, capacity, robustness, simplicity, validation, through put, etc., while meeting all regulatory, quality, and commercial requirements
About Us

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 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.

Why Join Us

We offer competitive salary ($140,000 - $160,000), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays, as well as time-off to volunteer in the community. We are proud to have been Certified as a Great Place to Work the last three years.

We are 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.



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