This position, which is located in San Clemente, is responsible for ensuring batches are reviewed, approved, and released on time for clinical and commercial operations. Timely and successful closure of deviations and CAPAs related to pharmaceutical operations. Ensure that learnings from one project are applied to others via knowledge management.
Oversight of third party manufacturers and clinical supplies distribution.
Oversee third party manufacturers, including batch record approval, review, deviation closure, batch release.
Oversee clinical supply third party distributer batch records, deviations, and batch releases for labeling and packaging operations.
New Product CMC team member providing compliance expertise for product definition.
Develop new batch records for projects moving into manufacturing
Provide insights into efficiency and robustness into documentation process and batch release process
5+ Years industry experience
Attention to detail and accuracy
Team player, good written.oral communicator
Able to thrive in a small, entrepreneurial environment
Fluent in FDA Part 211, ICH, and other regulatory guidance
Bachelor's degree, in a science or related field with relevant industry experience
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.