Associate Director, Validation

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Ocular Therapeutix, Inc. in Bedford, MA is seeking an Associate Director, Validation to provide strategic and technical leadership for validation across clinical development, process qualification, regulatory approval, and commercial launch.

You will lead PPQ, CPV, cold chain shipping validation, and packaging validation, while guiding lifecycle management and regulatory readiness and serving as a SME during inspections.

Qualifications

• Lead validation strategy and execution for PPQ, CPV, cold chain shipping validation, and packaging validation.
• Develop and maintain validation plans, PPQ strategies, protocols, reports, risk assessments, sampling plans, and acceptance criteria.

Responsibilities

• Lead validation strategy and execution for PPQ, CPV, Cold Chain Shipping Validation, and Packaging Validation.
• Develop and maintain product-specific validation plans, PPQ strategies, protocols, reports, risk assessments, sampling plans, and acceptance criteria.
• Lead cross-functional planning and execution of PPQ campaigns to support regulatory approval, commercial launch, and ongoing product lifecycle management.
• Ensure validation strategies appropriately integrate process development knowledge, process characterization, control strategies, equipment readiness, analytical readiness, and manufacturing experience.
• Establish and maintain CPV programs, including process monitoring, trending, evaluation of process capability and variability, and identification of emerging risks or adverse trends.
• Develop and oversee cold chain shipping and distribution validation strategies, including shipping configurations, temperature-controlled transportation, shipping lane qualification, thermal studies, and temperature excursion assessment.
• Provide validation leadership for packaging processes and systems supporting commercial product configuration, transportation, distribution, and product protection.
• Serve as a Validation Subject Matter Expert during regulatory inspections, audits, and CMC discussions.
• Provide technical leadership for validation-related deviations, investigations, change controls, risk assessments, and impact assessments.
• Maintain knowledge of evolving regulatory requirements and drive continuous improvement of validation systems and lifecycle approaches.
• Manage validation resources, consultants, and project priorities and provide

Skills

Validation leadership

Regulatory knowledge

Cross-functional collaboration

Process validation

PPQ

CPV

Regulatory inspections

Risk assessment

Lifecycle management

Project management

Job description

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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:

The Associate Director, Validation provides strategic and technical leadership for validation activities supporting the clinical development, process qualification, regulatory approval, and commercialization of Ocular Therapeutix products. This role has primary responsibility for Process Validation, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), Cold Chain Shipping Validation, and Packaging Validation, while providing broader validation leadership and support across the organization as needed.

The Associate Director is responsible for developing and executing validation strategies that demonstrate manufacturing processes, packaging configurations, and product distribution systems are capable, reproducible, and maintained in a state of control throughout the product lifecycle. This individual will play a critical leadership role in PPQ planning and execution, NDA readiness, commercial launch preparation, and ongoing lifecycle management of validated processes.

The Associate Director will serve as a validation subject matter expert during regulatory inspections, health authority interactions, audits, and CMC discussions and will maintain current knowledge of evolving regulatory expectations and industry practices related to process validation, lifecycle management, shipping validation, packaging validation, and continued process verification.

Principal Duties and Responsibilities include the following:

• Lead validation strategy and execution for Process Performance Qualification (PPQ), Continued Process Verification (CPV), Cold Chain Shipping Validation, and Packaging Validation.
• Develop and maintain product-specific validation plans, PPQ strategies, protocols, reports, risk assessments, sampling plans, and acceptance criteria.
• Lead cross-functional planning and execution of PPQ campaigns to support regulatory approval, commercial launch, and ongoing product lifecycle management.
• Ensure validation strategies appropriately integrate process development knowledge, process characterization, control strategies, equipment readiness, analytical readiness, and manufacturing experience.
• Establish and maintain CPV programs, including process monitoring, trending, evaluation of process capability and variability, and identification of emerging risks or adverse trends.
• Develop and oversee cold chain shipping and distribution validation strategies, including shipping configurations, temperature-controlled transportation, shipping lane qualification, thermal studies, and temperature excursion assessment.
• Provide validation leadership for packaging processes and systems supporting commercial product configuration, transportation, distribution, and product protection.
• Serve as a Validation Subject Matter Expert during regulatory inspections, audits, and CMC discussions.
• Provide technical leadership for validation-related deviations, investigations, change controls, risk assessments, and impact assessments.
• Maintain current knowledge of evolving regulatory requirements and industry practices and drive continuous improvement of validation systems and lifecycle approaches.
• Manage validation resources, consultants, and project priorities and provide