Principal Scientist

<p class=""p1"">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 the eyesight of people worldwide. Because we&rsquo;re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.</p>

Aliso Viejo, CA

Glaukos

<h4>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</h4> <h4>Our company was 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&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;inject&reg;&nbsp;device in September 2018 and iStent&nbsp;inject&reg;&nbsp;W in September 2020.</h4> <h4>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.</h4> https://www.glaukos.com/

keywords: about glaukos,position summary,prepare & review,design,duties,leadership,knowledge,experience,education,skills

Full time

Overview: <div class="basic-formatter" data-bind="html: job().corporateDescription"> <p>Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.</p> <p>Our company was 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&mdash;the iStent&reg;&mdash;in the United States, followed by our next-generation iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;device in September 2018 and iStent&nbsp;<em>inject</em><sup>&reg;</sup>&nbsp;W in September 2020.</p> <p>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.</p> <p>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 &ldquo;GKOS&rdquo;. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.<br /><br />Job Description<br /><br />Responsible for development of robust manufacturing and packaging processes during scale up and site changes. Design process development plan and oversee the operations of process scale up activities at in-house and at CDMO locations. Identify critical steps and implement controls in scale up process. Trouble shooting.</p> </div>
Responsibilities: <ul> <li>If required conduct mini unit operations around the critical steps identified in the manufacturing process &nbsp;to develop a robust process</li> <li>Design technology transfer plans and oversee the operations of product transfer &nbsp;from development site to commercial manufacturing site.</li> <li>Identify critical areas and conduct mini unit operations to gather process understanding during scale up and product transfers.</li> <li>Responsibilities include qualifying new raw materials (excipients and APIs), and primary pack components,&nbsp; recommending specifications for products and designing and evaluating product manufacturing processes using quality by design principles</li> <li>Design and execute protocols necessary to complete projects.</li> <li>Possess comprehensive knowledge of sterile filtration and aseptic fill and seal operations and techniques in areas of sterile liquid and semi-solids dosage forms supporting formulation development and scale-up.</li> <li>Prepare and review scientific documentation such as, laboratory notebooks, data analysis, regulatory reports, master formulae, manufacturing procedures, product development reports and SOPs.&nbsp;</li> <li>Author, review and approve development protocols and reports. Author procedures for cGMP manufacturing operations</li> <li>Prepare written reports for regulatory filings and documents all formulation and process development activities pursuant to cGMP standards.</li> <li>Support the qualification, calibration and maintenance of R&amp;D equipment in accordance with GLP/cGMPs.</li> <li>Ensure compliance with product quality, safety, performance and efficiency</li> <li>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.</li> <li>Develop systems that are cost effective and increase efficiency.</li> <li>Maintain and apply current knowledge of cGMP documents and guidance, other FDA/ICH guidance and SOPs.</li> <li>Coordinate with analytical chemists for completing testing of new drug products in a timely manner and developing appropriate controls.</li> </ul>
Requirements: <ul> <li>Ph.D&nbsp;&nbsp;or Master&rsquo;s or Bachelor&rsquo;s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or a related science.</li> <li>8 to 10 years of experience in process development and formulation of ophthalmic&nbsp; drug products</li> <li>Working knowledge of experimental designs and clinical manufacturing, validation, and report writing for regulatory submissions.</li> <li>Knowledge of product lifecycle &ndash; Product and process development,&nbsp; validation and regulatory submissions, commercial GMP manufacturing.</li> <li>Demonstrated knowledge of pharmaceutical manufacturing of ophthalmic products, sterilization methods, aseptic processing, and process development</li> <li>Proficient with interpreting and implementing cGMPs, cGLPs, ICH, USP, FDA, DEA and OSHA guidelines.</li> <li>Independent formulation research on enabling technologies and or unique delivery systems</li> <li>Excellent interpersonal and verbal/written communication skills that enable effective management and resolution of complex project-related issues involving collaborations with multiple functional areas</li> <li>Experience participating or leading tech transfers and writing technology transfer master plans and tech transfer reports. Reviewing of master batch records, stability protocol. Reviewing of RCA (root cause analysis) and &nbsp;deviation managements reports.</li> <li>Experience with pilot and commercial equipment for manufacture and filing of liquids and creams.</li> <li>Excellent presentation and communication skills</li> <li>Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions</li> <li>Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.</li> </ul> <br /><strong>Glaukos Corporation&nbsp;<em>is an Equal Opportunity/Affirmative Action Employer.&nbsp;</em></strong><em>All qualified applicants will receive consideration for employment<strong>&nbsp;</strong>without regard to race, color, religion, sex including sexual orientation and gender<strong>&nbsp;</strong>identity, national origin, disability, protected Veteran Status, or any other<strong>&nbsp;</strong>characteristic protected by applicable federal, state, or local law.</em>