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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 Senior Packaging Engineer I serves as a technical leader within the Package Development team, responsible for the design, qualification, and implementation of packaging systems supporting Gilead’s pharmaceutical and biologics pipeline. This role is essential for developing packaging solutions for combination products, device-integrated therapies, and temperature-sensitive and conventional dosage forms. The successful candidate will bring strong expertise in packaging engineering, regulatory compliance, and cross-functional collaboration to ensure packaging systems meet product, patient, and global regulatory requirements.

Specific Job Requirements

+ Lead the development and qualification of **primary, secondary, and tertiary packaging systems** for oral solids, parenteral, biologics, and combination products.

+ Apply advanced principles related to **container closure systems (CCS)** and **drug/device secondary packaging** , ensuring robust design and operational performance.

+ Manage packaging activities across **clinical development and commercialization** , ensuring timely execution and compliance with **cGMP** and regulatory standards.

+ Support **combination product packaging** , demonstrating familiarity with **design controls** , risk management, and applicable regulations (e.g., 21 CFR Part 4, ISO 11607).

+ Manage **material selection** , component characterization, and qualification of packaging systems and equipment.

+ Execute **equipment and process qualification** (IQ/OQ/PQ) for packaging configurations and manufacturing sites.

+ Design and author **packaging study protocols and technical reports** to support product development, stability, and regulatory submissions.

+ Draft and review **Standard Operating Procedures** ( **SOPs)** related to packaging development and departmental functions, ensuring alignment with broader organizational policies.

+ Contribute to **global regulatory filings** by authoring packaging-related sections for INDs, NDAs, BLAs, and other submissions.

+ Collaborate cross-functionally with **Regulatory, Quality, Supply Chain, Device Engineering** , and external partners to develop and implement optimal packaging solutions.

+ Monitor **industry trends** , emerging technologies (e.g., sustainable packaging), and evolving regulatory requirements.

+ Participate in **standards organizations** (e.g., USP, ISO, ASTM, ISTA) and contribute to internal packaging policy development.

+ Demonstrate **familiarity with temperature-controlled shipping container qualification** , including ISTA 7D methodology and supplier engagement.

+ Lead or contribute to **strategic initiatives** aimed at enhancing packaging capabilities and compliance.

+ **Mentor** or manage junior packaging engineers and serve as a technical lead on cross-functional teams.

+ Train new employees on SOPs, documentation systems, and packaging best practices.

+ Support packaging operations by resolving **deviations and investigations** in collaboration with Quality and Operations.

+ Initiate and manage **change controls** related to packaging systems and documentation.

+ Travel up to **20%** may be required to support external site activities and supplier collaboration.

Knowledge Requirements

+ Strong technical expertise in **packaging engineering and development methodologies** , with experience across biologics and traditional pharmaceutical dosage forms (e.g., oral solids, powders, suspensions, small molecules, and parenterals).

+ Familiarity with **combination product packaging** , including applicable regulatory requirements and **design control principles** .

+ Working knowledge of **FDA, cGMP** , and global regulatory guidance related to **container closure systems** and **temperature-controlled packaging** .

+ Proven ability to collaborate with **external suppliers** , **contract manufacturing organizations (CMOs)** , and contract test laboratories.

+ Strong **written, verbal, and interpersonal communication skills** , with the ability to clearly document and present technical work.

+ Proficient in **project management** , organizational planning, and use of relevant software tools for documentation and analysis.

+ Demonstrated ability to exercise **sound engineering judgment** in a fast-paced, dynamic environment.

+ Experience supporting packaging activities at **pharmaceutical CMOs** is highly desirable.

Basic Qualifications:

+ Doctorate OR

+ Master’s and 4+ years of relevant experience in a cGMP-related industry OR

+ Bachelor’s and 6+ years of relevant experience in a cGMP-related industry

Preferred Qualifications:

+ Degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field

+ Proven experience in a **cGMP-compliant environment** , with a strong understanding of regulatory expectations for pharmaceutical and biologics packaging.

+ Hands-on experience in **packaging development for injectable biologics, combination products** , and **temperature-sensitive pharmaceuticals** .

+ Familiarity with **TAPPI** , **ISTA** , and **ASTM** standards for packaging materials and systems, including mechanical and environmental testing protocols.

+ Demonstrated experience with **CAD-based packaging assembly drawings** , development of **protective and user-friendly secondary packaging features** , and implementation of **moisture barrier packaging solutions** for sensitive pharmaceutical and biologic products.

+ Experience using **electronic documentation systems** such as **Veeva** and **TrackWise** for managing quality and regulatory documentation.

+ Prior involvement in **shipping qualification** for biologic and combination products, including **thermal and mechanical validation** . Experience supporting **technology transfer** , **component qualification** , and **design history file (DHF)** development, including **design inputs** , **verification** , **validation** , and **human factors engineering (HFE)** in alignment with **FDA and ISO standards** .

+ Active participation in professional organizations (e.g., **PDA** , **ISPE** , **IoPP** ) or contributions to industry publications and conferences.

+ Experience leading or contributing to **sustainable packaging initiatives** , including material selection, recyclability, and life cycle assessments (LCA).

The salary range for this position is: $136,340.00 - $176,440.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

For jobs in the United States:

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

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 apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.