Senior Packaging Engineer II - San Mateo, United States - Gilead Sciences

Description

Senior Packaging Engineer II

United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale

Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

This position resides on the Package Development team at Gilead, where we create packaging solutions for our pharmaceutical and biologics pipeline. This role primarily focuses on developing and maintaining qualified controlled temperature packaging, with potential involvement in Primary and Secondary Package Development for oral solid dose and parenteral products.

Specific Job Requirements

• Provide technical leadership in temperature-controlled shipping containers, collaborating with stakeholders and suppliers to design solutions and execute qualification studies.
• Establish infrastructure for shipping container solutions, ensuring alignment with stakeholder needs.
• Develop processes for controlled container qualifications and temperature-controlled shipping qualifications for biologic products.
• Author packaging protocols and reports to support product development and regulatory filings.
• Author and review global regulatory filings and respond to questions related to container closure systems.
• Communicate project goals and results across cross-functional teams.
• Lead packaging activities for multiple clinical programs, ensuring on-time delivery and cGMP compliance.
• Execute packaging equipment and process verification and validation studies to prove the effectiveness of new packaging configurations and/or packaging lines/sites.
• Support packaging operations and drive resolution of deviations and investigations promptly.
• Perform characterization and qualification of primary packaging components.
• Write and review SOPs related to packaging, ensuring alignment with other Gilead SOPs.
• Monitor industry trends and best practices for package design technologies (e.g., novel packaging configurations, sustainability) and changes in the regulatory landscape related to container closure systems, secondary package design, and controlled temperature containers.
• Lead departmental strategic initiatives.
• Participate in standards organizations (e.g., USP, ISO, ASTM, ISTA).
• Serve as SME and mentor other packaging engineers in cold chain packaging.
• Potential for overnight travel up to 25%.

Knowledge

• Excellent technical skills and knowledge of package development principles.
• Specific experience in the biotechnology sector is preferred.
• Detailed understanding of component and line qualification.
• Knowledge of temperature-controlled shipping container qualification (ISTA 7D).
• Understanding of FDA and cGMP standards.
• Strong communication and organizational skills.
• Experience collaborating with external suppliers, contract manufacturing organizations, or contract test laboratories desirable.

Specific Education and Experience

• B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 8 years of relevant industry experience. OR
• M.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 6 years of relevant industry experience. OR
• PhD in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field and a minimum of 0 years of relevant industry experience.
• Advanced degree(s) with commensurate industry experience considered.

The salary range for this position is: $154, $199, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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*.

For additional benefits information, visit:

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

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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