Principal Quality Scientist

San Clemente, United States

Glaukos

Posted on: October 8, 2020

Closing: November 07, 2020

Salary: Undisclosed

Position Type: Full Time

Job Description

How will you make an impact?

The Principal Scientist, Quality Control, based in San Clemente, CA is responsible for providing technical expertise to the Quality Control group.  The Principal Scientist will support implementation/management of Laboratory Systems, including, but not limited to investigations, change controls, CAPA, inspection readiness, laboratory metrics and laboratory portfolio management.

What will you do?

  • Develop processes and procedures for raw materials, in-process testing, finished goods testing, and stability for multiple pharmaceutical products
  • Write/review laboratory Investigations
  • Oversee cGMP contract testing labs, including review and approval of analytical methods, method validations, and stability programs
  • Oversee internal testing approaches and evaluate internal versus external testing options
  • Recommend new equipment and techniques for the QC laboratory
  • Ensure Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies) meet ICH and other regulatory guidelines
  • Qualification and calibration of analytical equipment and/or approval of vendor qualification reports
  • Execution and/or approval of qualification, validation and stability protocols and/or reports
  • Prepare summary reports for submissions to regulatory agencies
  • Provide support to development and manufacturing projects through the attendance and participation in meetings as necessary
  • Provide technical leadership to the Quality Control chemists.  Take ownership of the QC laboratory and contribute to the strategic vision enabling QC to meet future company needs.
  • Work with Applied Research to identify, develop, and implement specialized approaches, techniques, and technologies to study drug potency, impurity levels, elution rates, and local drug distribution.
  • Perform feasibility testing to assess new methods prior to implementation in the QC lab
  • Design, author and execute test method validation protocols and reports.
  • Oversee execute and/or review routine QC testing and generate the associated documentation (reports, COAs, etc.).
  • Manage cGMP stability programs for clinical development and commercial products.  Perform trend analysis on applicable stability data.
  • Oversee management of the internal reference standard program.
  • Provide schedules and updates on QC activities including in-process testing, batch release testing and stability reporting.
  • Act as the primary technical expert for pharmaceutical OOS, OOT and investigations.
  • Evaluate the capabilities of new CROs/CMOs and support vendor audits.
  • Monitor and ensure QC compliance with ICH, USP, Pharm. Eur., JP and applicable regulatory guidance.
  • Perform method transfers to in-house QC lab or to outside testing labs.
  • Monitor progress of contract and internal analytical studies.
  • Identify and solve problems to facilitate the progress of projects.  Design experiments to solve technical problems in method transfer and assay implementation for small molecule compounds.
  • Perform routine maintenance and troubleshooting of lab instruments effectively.  Provide suggestions for the purchase of equipment and evaluate potential use of new technologies.
  • Analyze and interpret complex data sets efficiently and accurately.  Make recommendations using professional judgment to impact drug development, and regulatory requirements.
  • Act as Department representative on various cross-functional teams and development project teams and participate in various task forces, such as providing technical and/or general administrative expertise, drafting or updating relevant SOPs and maintaining smooth workflow.
  • Contribute to team discussions and communicate significant and relevant events and action items to appropriate departmental members and project team representatives in a timely manner.

How will you get here?

  • B.S. Degree in a Scientific field with 15+ years of industry experience.
  • M.S. degree in a Scientific field with 10+ years of industry experience.
  • PhD in a in a Scientific field with 5+ years of industry experience.

Requirements:

  • 12+ years of experience in analytical chemistry (QC and/or R&D)
  • At least 4 years in a technical leadership role in a Pharmaceutical QC Lab.
  • Demonstrated capability to act as an analytical chemistry SME.  Highly competent with HPLC, FTIR, UV/vis and Dissolution/Drug Release.
  • Experience with analytical method validation, method transfer and managing stability programs.
  • Experience managing external contract labs is desirable.
  • Strong technical writing and presentation skills.
  • Proven ability to work independently at a high level and provide strong technical guidance to junior scientist and QC chemists.
  • High degree of familiarity with ICH, major pharmaceutical compendia, CTD and applicable regulatory guidance.
  • Good working knowledge of statistics used in the QC laboratory.

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.

Those may seem like big aspirations, but 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 eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous paid time off & paid holidays as well as time-off to volunteer in the 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. Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!

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.

ABOUT US

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.

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—the iStent®—in the United States, followed by our next-generation iStent inject® device in September 2018.

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.

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 “GKOS”. Our global headquarters is located in San Clemente, California with additional locations in Waltham and Burlington, Massachusetts.

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.

Glaukos

Posted on: October 8, 2020

Closing: November 07, 2020

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Chemistry, Quality