Research Associate II, Quality Control
Ocular Therapeutix
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.
Job description
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
Requirements
- 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
Company overview
Ocular Therapeutix, Inc. is a publicly traded biopharmaceutical company headquartered in Bedford, Massachusetts, specializing in innovative therapies for ocular diseases and conditions. Founded in 2006, the company leverages its proprietary hydrogel platform technology to develop sustained-release drug delivery systems that overcome limitations of traditional eye-drop therapies. Ocular Therapeutix focuses primarily on retinal diseases, with its leading investigational candidate AXPAXLI™ (OTX-TKI) currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD). The company's ELUTYX™ technology enables controlled release of therapeutic agents through intravitreal injection, potentially reducing treatment burden for patients with chronic retinal conditions. With approximately 274 employees and trading on NASDAQ under the symbol OCUL, Ocular Therapeutix is committed to redefining the retina experience across drug development, treatment, and patient outcomes.