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Research Associate II, Quality Control

Job Overview

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Employment Type

Full-time
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Compensation

Salary
Range $85,000.00 - $93,000.00
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Benefits

Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Disability insurance
Life insurance
Employee assistance program

Job Description

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a distinguished biopharmaceutical company dedicated to the formulation, development, and commercialization of innovative therapies targeting diseases and conditions of the eye. Leveraging its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™, the company has pioneered unique drug delivery solutions that aim to reduce the complexity and burden typically associated with current standard treatments. Ocular Therapeutix has established a robust product pipeline focusing on ophthalmic drug delivery methods that position it as a future leader in the ophthalmic space. The company operates with a strong commitment to scientific innovation, patient-centered therapies, and cutting-edge technological advancements within the pharmaceutical industry focused on eye care.

Ocular Therapeutix is headquartered in Bedford, Massachusetts, where it fosters an inclusive, dynamic work culture designed to encourage creativity, cross-functional collaboration, and out-of-the-box thinking. The company prioritizes the professional growth and success of its employees by promoting a supportive environment and offering opportunities that enable individuals to achieve their career objectives. This supportive culture underpins their continued commitment to innovation and excellence in research.

We are currently seeking a Research Associate II to join our Analytical Development group. This full-time position involves engaging in routine Quality Control (QC) testing activities, supporting CAPAs, change controls, investigations, and deviations, alongside contributing to the development and validation of analytical methods. The salary range for this role is $85,000 to $93,000 USD. As a Research Associate II, you will work closely with laboratory equipment and instrumentation such as HPLC, UPLC, GC, Karl Fischer titration, and dissolution systems, ensuring precision and adherence to rigorous quality standards. Your responsibilities will include timely authoring of technical reports, maintaining up-to-date instrumentation calibration and qualifications, troubleshooting analytical equipment issues, and coordinating repairs when needed.

Beyond the technical tasks, you will play a vital role in data review, project support, and laboratory upkeep, maintaining thorough documentation in compliance with cGMP and Good Documentation Practices. You will support the coordination of external testing and interface with Quality Assurance to ensure the timely closure of CAPAs, change controls, investigations, and deviations. This position requires a strong foundational chemistry background, meticulous attention to detail, and a solid understanding of regulatory practices and safe laboratory standards. Your contribution will directly impact the quality and efficacy of the company’s drug development initiatives, underpinning Ocular Therapeutix’s mission to be at the forefront of innovative ophthalmic therapies. Join Ocular Therapeutix and be part of an inspiring team dedicated to advancing eye care treatment while building a fulfilling career in a progressive and compliant research environment.

Job Requirements

  • Bachelor's degree in Chemistry or related field
  • 2+ years of work experience in a GMP Quality Control environment
  • Prior experience with HPLC and UPLC
  • Knowledge of CFR 210,211, USP and FDA/ICH guidance is preferred
  • Knowledge of safe laboratory practices
  • Strong verbal and written communication skills
  • Experience with USP App IV dissolution apparatus is preferred

Job Qualifications

  • Bachelor's degree in Chemistry or related field
  • 2+ years of work experience in a GMP Quality Control environment
  • Prior experience with HPLC and UPLC
  • Knowledge of CFR 210,211, USP and FDA/ICH guidance is preferred
  • Knowledge of safe laboratory practices
  • Strong verbal and written communication skills
  • Experience with USP App IV dissolution apparatus is preferred

Job Duties

  • Support QC analytical chemistry testing using laboratory equipment and instrumentation such as HPLC, UPLC, GC, Karl Fischer titration, and dissolution apparatus
  • 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
  • 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

Job Criteria

Experience

Mid Level (3-7 years)


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