Sr. Engineer II, Pharmaceutical
The Senior Engineer II, Pilot Operations Pharmaceutical, based in San Clemente, CA 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 help support 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:
- Product development reports
- Analytical method validation package for API, excipients, and finished products
- Container-closure selections
- Master and executed batch records
- Batch stability reports
- Microbiological validation, including aseptic filters
- Aseptic-fill validation package
- Labeling packages
This role will have the responsibilities to:
- 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.
- Supports 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, through put, 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 campaigns.
To be successful in this role, a minimum of Bachelor's degree is required. A BS in Engineering or Science is preferred. CPIP Certification is also preferred. You'll need to bring 8-to 12-years of experience, a minimum of 4-years of pharmaceutical experience required and 8-years is preferred. Pharmaceutical experience is required.Experience with medical device is a plus. You will also have experience in the following of areas:
- Drug, Device and Drug/Device combination product experience strongly preferred.
- Experience with aseptic fill
- Experience with clean room GMP / GLP environments (ISO5-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.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex including sexual orientation and genderidentity, national origin, disability, protected Veteran Status, or any othercharacteristic protected by applicable federal, state, or local law.
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its 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.
The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
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