Manager, Process Validation at Glaukos Corporation in Boston, Massachusetts

Job Description:

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.

How will you make an impact?

The Manager, Pharmaceutical Process Validation Engineer position, based in Burlington, MA, will report to the Director of Operations. The candidate will support process validation, process development, process scale-up, transfer from R&D to clinical and commercial manufacture, process validation and commercial operations at CMOs.  Responsible for GMP engineering runs, process validation and commercial manufacture at external CDMOs.  This is a hands-on role partnering across functions.

 

What will you do?

·       Drug substance and drug product API pharmaceutical manufacturing process, process validation, commercial operations, process development

·       Leadership role with potential direct reports

·       Utilize the elements of QBD and ICH 8,9,10,11 as appropriate in development programs

·       Responsible for scale up, technical transfer, process validation and commercial operations technical support

·       Risk assess and identify Critical Quality Attributes (CQA), Critical Process Parameters (CPP) and process control strategy.  Perform manufacturability assessments for technical transfer and comparability assessments between sending and receiving sites.

·       Responsible for the technical transfer process from R&D to Pilot, Clinical and Commercial Operations including process validation and successful product filings.

·       Develop and execute a tech transfer plan and process validation protocol at CDMO.

·       Responsible for supporting clinical and commercial production whether internal or at CDMO.

·       Build trusting relationship with CDMOs

·       Support process deviations and product impact assessments, root cause investigations and implement CAPA to avoid recurrence of issues.

·       Convey a clear understanding of manufacturing and quality regulations. Foster a collaborative working relationship with R&D and Quality to ensure that documentation complies with pharmaceutical drug regulations.

·       Responsible for timelines, execution (hands-on), protocols, reports, including process engineering and process validation protocols and reports. 

·       Represents Operations on drug project teams. Develops robust manufacturing process’ in accordance with Corporate objectives

·       Require domestic travel of up to 1 weeks at a time during off-site operations (CDMO). 
 

·       How will you get here?

Education:

·       Bachelor’s degree, in a Biology, Chemistry, or Engineering field.    Advanced degrees or qualifications desirable. 

 

Requirements:

 

·       Senior Level: 8-10 years direct Drug product API pharmaceutical process validation, process development, technology transfer experience in clinical and/or commercial GMP setting within a pharmaceutical or biotechnology environment.

·       Prior experience with a successful product filing with experience in process development, technical transfer and process validation

·       Prior experience supporting commercial operations, product life cycle management, continued process verification (CPV)

·       Full working knowledge of 21CFR Part 210/211 and other regulatory guidelines (ICH, WHO, EU, etc.)

·       Partnering with CDMOs

·       Process deviations, product impact assessments, root cause investigations and CAPA.

·       Experience with aseptic syringe filling and process troubleshooting

·       Knowledge of principles of drug process development and process optimization

·       Knowledge of equipment, facility, and utility validation (IQ/OQ/PQ and CSV)

·       Working knowledge of aseptic manufacturing processes

 

·       Attention to detail and accuracy

·       Team player

·       Good written/oral communication

 

·       Able to thrive in a small, entrepreneurial environment

 

·       Must be organized and able to coordinate activities with internal departments and outside vendors

·       Ability to effectively negotiate and build collaboration

·       Proficient in computer skills (e.g. Word, Excel, Power Point)

·       Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

 

     

 

 

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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