Research Associate II, Quality Control

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary:

This is an exciting time to join our Quality Control team in executing routine quality control testing supporting critical late-stage program activities. You will perform CAPA’s, change controls, investigations, and deviations and participate in the development and validation of analytical methods for the Analytical Development group. In addition to testing this role will be responsible for project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory. 

Duties and Responsibilities:

• Support QC Analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, Dissolution etc.).
• Author technical reports as required.
• Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.
• Troubleshoot any issues with instrumentation and coordinate repair with vendors as necessary.
• Coordinate with supervisor on scheduling of testing for reagents and product samples.
• Participate in data review activities.
• Participate in method development and validation activities.
• Coordinate external outsourcing of testing.
• Support CAPA, change controls, investigations, and deviations and the timely closure of these items with Quality Assurance.
• Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.).
• Adherence to cGMPs at all times.

Qualifications:

• Bachelor’s degree in chemistry or related field is required
• 2+ years of relevant work experience is required, ideally in a quality control function
• 1+ years of HPLC / UPLC work experience is required
• 1+ years of experience in a GMP environment is required
• Knowledge of CFR 210, 211, USP and FDA/ICH guidance is preferred
• Knowledge of safe laboratory practices is essential
• Strong verbal and written communication skills
• Experience with USP App IV dissolution apparatus is preferred
• Ability to work in both office and chemical laboratory environments is required

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Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.