Associate Director Packaging Development

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Job Description

The Associate Director Packaging Development is a senior-level individual contributor within the PackagingDevelopment organization responsible for providing technical leadership for packaging development qualification and commercialization activities for combination position serves as the subject matter expert (SME) responsible for defining packaging strategies that support successful regulatory submissions and commercialization of combination products.

This role will shape and define combination product packaging processes and establish the governance and operating framework for Packaging Engineering across the combination product ecosystem. The Associate Director will serve as the primary Packaging Engineering representative within the combination product ecosystem driving cross-functional alignment and resolution of complex technical and organizational issues.

In addition while serving as the Combination Product Packaging SME this role will independently lead packaging development programs across multiple product modalities and may be accountable for development qualification and commercialization activities supporting biologics and oral solid dose (OSD) products based on business priorities and organizational needs.

The roleoperateswith a high degree of independence provides technical mentorship to otherengineers and helps define the long-term operating model for Packaging Engineering within the combination product ecosystem.

This is an on-site rolelocatedat Gilead headquarters in Foster City California.

Key Responsibilities:

Strategy & Governance

• 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.

Technical Leadership

• 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.

Program Execution

• 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.

Cross-Functional Integration

• 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.

Documentation & Continuous Improvement

• 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.

• Identifyopportunities for continuous improvement and standardization within Packaging Development.

Miscellaneous

• Travel up to 20%.

Knowledge

• Excellent technical knowledge of packaging engineering package development qualification and commercialization methodologies is required. Experience leading combination product packaging development programs is required. Experience supporting biologics packaging systems shipping qualification distribution strategies and cold chain packaging is strongly preferred.

• 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.

• 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.

• 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 ISOCFR PartsASTM/ISTA transportation standards

Basic Qualifications

• 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. Advanced degree(s) with commensurate industry experience is also considered.

• Prior experience in a cGMP-related industry is required.

• 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.

For additional benefits information visit:

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

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 disabilitygenetic 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 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 for assistance.

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