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Associate Director, Validation at Ocular Therapeutix - ApplyBlast

Associate Director, Validation

Ocular Therapeutix

1 month ago

4.1 on Glassdoor

Bedford, Massachusetts, United States

Onsite

Full Time

Director

0 applicants

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About this role

The Associate Director, Validation provides strategic and technical leadership for validation activities supporting clinical development, process qualification, regulatory approval, and commercialization of Ocular Therapeutix products. This role oversees process performance qualification, continued process verification, cold chain shipping validation, and packaging validation, while serving as a subject matter expert during regulatory inspections and audits.

Responsibilities

Lead validation strategy and execution for PPQ, CPV, cold chain shipping, and packaging
Develop and maintain product-specific validation plans, protocols, and reports
Serve as validation subject matter expert during regulatory inspections and audits

Skills

Qualifications

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or Pharmaceutics

About Ocular Therapeutix

ocutx.com

Headquarters

Bedford, Massachusetts, United States

Company Size

51-200 employees

Founded

2006

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Ocular Therapeutix is an ophthalmic biopharmaceutical company focused on developing innovative treatments for retinal diseases. Its lead program, AXPAXLI™, is a sustained‑release hydrogel therapy in development as a potential treatment for wet age‑related macular degeneration (wet AMD), designed to extend drug exposure and reduce injection frequency. The company develops and aims to commercialize ophthalmic products that improve outcomes for people with retinal disease. Ocular Therapeutix combines drug formulation and ocular drug‑delivery technology to redefine treatment approaches in retinal care.