Assoc Director, Device Engineering

Overview

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Device Engineering team at Gilead is seeking a qualified Associate Director of Device Engineering to drive commercial readiness and manage the life cycle of drug-device combination products. This individual will be responsible for leading cross functional teams to establish new manufacturing sites and commercialize new products. Expertise in design controls, process development, new product introduction, design transfer, and process validation is essential.

Job Responsibilities

• Lead cross-functional team to complete design transfer to internal and external manufacturing sites – including executing process characterization studies, selecting and specifying manufacturing equipment, and authoring/reviewing design control documents.

• Lead product and / or process improvement projects.

• Lead quality and business process improvement projects.

• Mentor junior engineers.

• Manage technical issues with legacy device components of combination products to ensure supply chain continuity.

• Provide technical support for manufacturing site selection activities.

• Implement harmonized risk management for legacy products per ISO 14971.

Qualifications

Basic Qualifications:

• Doctorate and 5+ years of relevant experience OR

• Master’s and 8+ years of relevant experience OR

• Bachelor’s and 10+ years of relevant experience OR

Preferred Qualifications:

• Expertise running multifunctional teams and managing technical issues at contract manufacturing organizations.

• Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.

• Expertise working with equipment vendors and manufacturers including creating RFPs, developing user requirements, and qualifying equipment.

• Experience with design, execution, and statistical analysis of process characterization studies.

• Execution of root cause analysis, deviation management, and investigation.

• Strong verbal, written, and interpersonal communication skills are required.

• Must be able to write clear, concise, and error-free documents.

Compensation and Benefits

The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For additional benefits information, visit:

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