Sr Packaging Engineer II

Senior Packaging Engineer II, Package Development and Operations

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Qualified candidates will focus on developing primary, secondary, and controlled temperature packaging. We seek a motivated, detail-oriented individual with excellent technical writing and communication skills.

Specific Job Requirements

• Provide technical leadership in the application of advanced theories, concepts, principles, processes, and testing methodologies related to container closure systems and drug/device secondary packaging design and operations.
• Manages primary, secondary, and tertiary material selection, primary packaging operations, and qualification of packaging and equipment
• Develop, write, and execute internal packaging procedures/protocols and reports that support product development and regulatory filing needs.
• Author and review department portions of regulatory submissions and response questions related to package design and components.
• Interact effectively with cross-functional teams to develop optimal packaging solutions.
• 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.
• Participate in standards organizations (e.g., USP, ISO, ASTM, ISTA) and establish pharmaceutical and biotechnology packaging policies.
• Effectively communicate ideas, project goals, and results to team members across cross-functional roles/departments.
• Lead packaging activities in support of multiple clinical programs in all phases of development, ensuring on-time delivery of project deliverables and compliance to current Good Manufacturing Practice (cGMP)..
• Execute qualification studies for controlled temperature shipping containers and author related reports.
• Lead departmental strategic initiatives.
• May manage packaging engineers while also serving as the lead on project teams.
• Overnight travel may be required up to 25% of time.

Knowledge, Experience, and Skills:

• A Bachelor's degree in packaging engineering, mechanical engineering, or a related scientific field and a minimum of 8 years of relevant industry experience.
• Excellent technical skills and knowledge of packaging engineering and package development methodologies are required, preferably in biologics and traditional pharmaceuticals (e.g., solid dosage, oral powders, suspensions, small molecule parenterals).
• Strong computer, organizational, and project management skills are required.
• Strong verbal, written, and interpersonal communication skills are required.
• Must be able to exercise judgment in a fast-paced, dynamic work environment
• Experience working with Pharmaceutical Packaging CMOs is desired.
• Experience with Controlled Temperature, Combination, and Device packaging is preferred.
• Working knowledge of the FDA and cGMP standards and global regulatory guidance related to container closure systems and controlled containers.