Associate Director Packaging Development

Gilead Sciences • Foster City, CA

2d • $182,070 - $235,620

About The Position

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.

Requirements

• Excellent technical knowledge of packaging engineering, package development, qualification, and commercialization methodologies is required.
• Experience leading combination product packaging development programs is required.
• Demonstrated experience working within combination product development teams and collaborating closely with Device Engineering, Quality, Human Factors Engineering, and Regulatory Affairs.
• Strong understanding of design controls, risk management, change control, and the interfaces between pharmaceutical and device quality systems.
• Proven ability to influence without authority and successfully navigate technical disagreements across multiple disciplines in a matrixed organization.
• Strong computer, organizational, and project management skills are required.
• Must be able to exercise judgment in a fast-paced, dynamic work environment.
• Working knowledge of applicable regulations and standards, including FDA combination product requirements, EU MDR, ISO 11607, ISO 14971, 21 CFR Parts 210, 211, 820, ASTM/ISTA transportation standards.
• B.S. degree in packaging, industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, or a related scientific field and a minimum of 10 years of relevant industry experience is required.
• Prior experience in a cGMP-related industry is required.

Nice To Haves

• Experience supporting biologics packaging systems, shipping qualification, distribution strategies, and cold chain packaging is strongly preferred.
• Experience establishing governance frameworks, operating models, and cross-functional ways of working within a matrixed organization is highly desired.
• Experience with traditional pharmaceutical packaging (e.g., OSD) is desirable.
• Advanced degree(s) with commensurate industry experience is also considered.
• Experience working with Pharmaceutical Packaging CMOs is desired.
• Experience leading packaging development programs through NDA and/or BLA submissions is preferred.
• Experience supporting biologics packaging systems, cold chain distribution, and transportation qualification activities is highly desirable.

Responsibilities

• Provide vision and leadership to build and integrate combination product packaging development processes into the Gilead ecosystem.
• Develop and maintain governance, roles, responsibilities, and decision-making processes that define interfaces between Packaging Engineering, Device Engineering, Device Quality, Regulatory Affairs, and other key stakeholders.
• Define and continuously improve the operating model, workflows, and best practices that support effective execution and cross-functional collaboration across combination product, biologics, and pharmaceutical development programs.
• Lead resolution of complex issues involving Packaging Engineering and cross-functional stakeholders.
• Provide technical leadership during design reviews, risk assessments, change management activities, and governance forums.
• Lead or support design control activities, ensuring packaging requirements are appropriately incorporated into design, risk management, verification, validation, and change management processes.
• Participate in hazard analysis and risk assessments related to packaging and distribution.
• Lead packaging development, qualification, and commercialization activities for assigned combination product, biologics, and OSD programs.
• Assess packaging manufacturing networks, identify capability gaps, and develop strategies to support future portfolio needs.
• Evaluate and select packaging materials, components, equipment, and technologies.
• Identify, evaluate, and manage CMOs and external advisors.
• Collaborate with Human Factors Engineering and Human-Centered Design to ensure packaging is integrated into the overall product system.
• Interact effectively with cross-functional teams to develop optimal packaging solutions.
• Communicate project goals, strategies, and results across functional organizations.
• Author technical documents, packaging procedures, governance models, standards, and best practices.
• Author and review packaging-related sections of regulatory submissions and health authority responses.
• Serve as a mentor and technical resource for packaging engineers.
• Identify opportunities for continuous improvement and standardization within Packaging Development.
• Travel up to 20%.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans.
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree