Assoc Director, Packaging Engineer

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. We’re looking for passionate and ambitious people ready to make a direct impact.

• Develop and champion internal business processes to support commercial readiness and lifecycle management of primary container closure systems used in drug product manufacturing.
• Serve as the technical lead and manage technical relationships with suppliers of primary container closure components.
• Monitor evolving compendial standards and lead initiatives to ensure continued compliance with regulatory requirements.
• Support extremely complex technical problems related to primary container closure systems that advance Gilead portfolio priorities.
• Execute studies and author reports related to container closure system compatibility and manufacturing process development.
• Evaluate new/novel technologies relevant to parenteral drug product manufacturing.
• Represent process technologies and development in cross‑functional project teams.
• Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions.
• Serve as a subject matter expert for development and commercial sterile processing operations.
• Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members.

• Expertise running multifunctional teams and managing technical issues at suppliers and contract manufacturing organizations.
• Expertise working with equipment vendors and manufacturers, process validation, and process characterization studies.
• Execution of root cause analysis, deviation management, and investigation.

• Excellent verbal, written, and interpersonal communication skills are required.
• Must be able to write clear, concise, and error‑free documents.
• Expert knowledge of FDA and cGMP standards and sterile processing.

• BA with 10+ years of experience.
• OR MS with 8+ years of experience.
• OR PhD with 2+ years of experience.

The salary range for this position is: $ - $. This position may also be eligible for a discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package.

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. Employment decisions are based on qualifications and performance with no discrimination based on protected characteristics under applicable law.