Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Sr. Engineer, Pilot Operations, Pharma, based in San Clemente, California is a newly created role within the Pilot Operations organization and will be responsible for clinical and pilot commercial manufacturing for pharmaceutical products. The incumbent will manage both outside CMOs as well as in internal manufacturing of the pharmaceutical component of Glaukos' clinical and pilot commercial combo product build campaigns. This will be a hands-on role partnering with technicians to manufacture supplies as needed. The function will be supported by pharmaceutical and device engineers, and technicians. Additionally the incumbent will partner with R&D on Tech Transfer of CMC activities which may include assisting with or leading:
Product development reports
Analytical method validation package for API, excipients, and finished products
Master and executed batch records
Batch stability reports
Microbiological validation, including aseptic filters
Aseptic-fill validation package
Responsible for completing clinical and stability supply campaigns, as well as additional builds as needed for sterilization validation, design verification, PK, Tox, and all other component/product needs.
• Responsible for initial commercial production whether internal or at CMO.
• Coordinates activities and support of technicians, raw material component suppliers, service providers including package testing, sterilizers, CMO, maintenance and calibration activities, shipping of equipment and supplies, etc. as needed in support of fill campaigns.
• Manages all component and final product deliverables for accuracy and schedule, to support stability studies, validations, clinical supplies, research needs, methods development and validation, special studies, samples, etc.
• Works with Glaukos' Device Pilot Production and the Supply Chain group to ensure that device component portion of combo product preparation at Glaukos is completed properly and on time to support drug/combo product build campaigns. This includes assisting with Process development, method development, test method development, Batch and Lot history record development, etc.
• Responsible for meeting all drug/combo WW product development and manufacturing regulations and quality requirements. Partner with Quality to ensure that Quality System documents appropriately complies with Drug and combo product regulations.
• Responsible for sterilization, package integrity and equipment validations for assigned pharmaceutical production projects and equipment, as well as stability studies for select combo/drug projects
• Responsible for in house manufacturing of pre-clinical stability, biocompatibility, Tox, PK supplies for assigned products.
• Represents the Pilot Ops department on drug/combo to project teams and develops robust manufacturing processes meeting Corporate/Operations objectives for cost, quality, manufacturability, vendor quality, capacity, robustness, simplicity, validation, throughput, etc., while meeting all regulatory, quality, and commercial requirements.
• Partner with R&D to drive process improvements prior to scale up.
• Ensures that requirements and process for transfer of research / development projects into Clinical manufacturing are met/followed.
• Requires domestic travel of up to 3 weeks at a time during off-site fill campaign
• Minimum of 4+ years of broad experience in Pharmaceutical Development and Manufacturing at both clinical and production scale.
• Drug, Device and Drug/Device combination product experience strongly preferred.
• Experience with aseptic fill
• Experience with clean room GMP / GLP environments (ISO 5-ISO 8)
• A strong combination of technical, business, and project management skills is required.
• Experience developing processes, equipment, specs, procedures, training, etc. at pilot clinical/commercial scale to ease transition and pave the way for later transfer to full production.
• Prior experience working with Purchasing and component/API/excipient vendors to manage drug/combo component purchasing, inventory, and manufacturing to ensure all supplies are properly documented and available when and how needed, including device components and processes.
• Experience with documentation and organization of development, manufacturing, validations, studies, builds, components, etc. in a manner that meets drug and device GMP requirements and in preparation for preparing CMC section of IND/NDAs dealing with manufacturing processes.
• Experience coordinating with Clinical Operations group to ensure smooth transition from manufacturing to distribution to domestic and international study sites.
• Experience with set up of randomization and distribution systems such as IRT set-up and coordination with the CMO.
• Success in developing scaled up process/equipment and transfer from Pilot to full Production in anticipation of US FDA approval.
• Provides training and production ready documentation, and assists with equipment selection/qualification and process and setup.
• Requires a minimum Bachelor's degree. A BS in Engineering or Science is preferred. CPIP Certification preferred
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our 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: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
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.
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