Quality Chemist II

Glaukos - San Clemente, CA (30+ days ago)3.0

Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our 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. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.

Position Overview:
The Quality Chemist II must have extensive GMP analytical testing experience, method transfer and validation experience. The Quality Chemist II will be responsible for developing, implementing analytical methods, creating/revising GMP documents, testing raw materials, performing in-process and final product release. The Quality Chemist II supports the manufacture of product formulations including reviewing Batch records, lot release, executing investigations, procurement of equipment and supplies.

Primary Responsibilities:
We are a growing business and in the process of transforming into a drug-combo business. This role will focus in the short term on establishing the labs and developing control testing.

Performing quality control testing and/or release of cGMP materials (for example, advanced Intermediates and Active Pharmaceutical Ingredients) in accordance to cGMP requirements

Execution and maintenance of Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies.

Ensuring that the quality control laboratory is functional and equipped with equipment/utensils and test materials as needed and in a state of compliance

Set up instruments and conduct sample tests; utilize a variety of methods to assure compliance to established standards and testing controls

Troubleshoot, clean and maintain instruments, glassware and equipment; conduct preliminary diagnostic test on equipment

We are going to have ongoing needs where we’ll need experience in:

Experienced in batch manufacturing and record keeping of batch productions; perform batch review and release

Qualification and calibration of analytical equipment and/or approval of calibration results

Execution and/or approval of qualification, validation and stability protocols and/or reports

Perform a variety of analytical laboratory testing of raw material, processed material and finished products and assure compliance with applicable laws, rules and regulations

Operate a variety of test equipment, such as HPLC, spectrophotometer, pH meter, filtration devices, hot plates, TDS, Moisture Apparatus, Melting Point, balances, etc.

Conduct a variety of analytical lab tests in compliance with standard testing methods, procedures and regulations; implement quality control specifications

Interpret test results and prepare and submit reports related to test results

Perform, interpret, evaluate and record standard process control laboratory tests on

Perform calculations as needed and record results; notify appropriate personnel of abnormal or critical results and significant changes in lab results.

Assure materials meet standards of cleanliness to assure accurate test results.

Assure an adequate supply of test materials to perform daily testing; perform preventive maintenance on equipment

Oversees laboratory equipment (PM, Calibrations), procurement and validation of analytical equipment/supplies

Prepare periodic and special reports concerning quality control and results of laboratory tests; prepare analytical results reports to relay qualitative and quantitative data; submit to manager of quality

Work Experience:
Experienced performing in-depth investigations, i.e. out of specification (OOS), must have strong analytical skills, ability to troubleshoot analytical methods and technical writing abilities

4+ years’ experience

GLP/GMP experience required

Analytical experience (USP, EP, JP etc.)

Regulatory knowledge (FDA, ISO, ICH, etc.)

Pharma/Medical Device cGMP, GMP manufacturing experience

Knowledge, Skills, and Abilities

Helping create a positive work environment

Ability to manage simultaneous projects.

Demonstrated strong leadership, team building and advanced coaching skills.

Ability to work with teams and lead decision-making processes in a team environment.

Excellent communicator with the ability to influence and persuade across all levels of the organization as well as with suppliers and customers, exercising a high degree of tact and diplomacy to accomplish objectives.

Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.

Ability to build, coach and motivate high performance teams, while holding employees accountable for results.

Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.

Knowledge of quality management systems and corrective action programs.

Bachelors of Science in chemistry, biochemistry, or related field (required); masters preferred

We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our 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: https://www.themuse.com/companies/glaukoscorporation

Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf 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.