Sr Packaging Engineer II

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 is in the Gilead External Manufacturing group, which is part of Gilead Manufacturing Operations organization. This role is in the Gilead Foster City location.

Key Responsibilities:

Commercial Packaging & External Manufacturing Support

• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of deviations, complaints, and investigations related to packaging, labeling, and logistics.
• Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.
• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.

Cross-Functional Partnership & Supply Continuity

• Partner closely with Supply Chain, Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.
• Represent Packaging & Labeling on CMC teams, supporting lifecycle management activities for Gilead products.
• Support department leadership with resource planning and financial reporting activities.

Packaging Development & Documentation

• Review and approve specifications for primary, secondary, and tertiary packaging components used for commercial products.
• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.
• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for parenteral finished goods, including small molecules, biologics, and combination products.

Technology Transfer & Validation

• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.
• Participate in or lead packaging process validation activities for parenteral products across global manufacturing networks.

Compliance & Regulatory Oversight

• Maintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.
• Support regulatory submissions, inspections, and responses related to packaging and labeling activities, as needed.

Basic Qualifications:

• Bachelor's degree in Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related technical field with at least 8 years of relevant industry experience,

OR

• Master's degree in a related field with at least 6 years of relevant industry experience.

Knowledge, Experience And Skills

• Strong knowledge of cGMPs, pharmaceutical manufacturing principles, and global packaging standards.
• Technical proficiency, independent thinking, teamwork and collaboration, including driving continuous improvement.
• Demonstrated experience with secondary and tertiary packaging for parenteral products (small molecules and biologics).
• Experience supporting new product introductions, technology transfers, and commercial launches in major global markets.
• Experience with leading investigations and identifying appropriate CAPAs to prevent recurrence
• Proven experience working with and managing external contract packaging organizations.
• Proven experience leading complex, cross-functional projects across multiple regions and time zones. Proficient at using project management tools to develop detailed timelines. Identify risks and critical path items on the project timeline.
• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD) (preferred).
• Knowledge of distribution and cold chain shipping requirements for parenteral products; experience with shipping qualifications and transportation studies.
• Financial acumen related to budgeting, forecasting, and cost optimization.
• Working knowledge of statistical methods and software to support packaging process optimization and troubleshooting.

The salary range for this position is: $157,590.00 - $203,940.00. 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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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 View email address on click.appcast.io for assistance.

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For Current Gilead Employees and Contractors:

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