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 role operates with a high degree of independence, provides technical mentorship to other engineers, and helps define the long-term operating model for Packaging Engineering within the combination product ecosystem.
This is an on-site role, located at 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.
Identify opportunities 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, ISO 14971, 21 CFR Parts 210, 211, 820, ASTM/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.
The salary range for this position is: $182,070.00 - $235,620.00. 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.
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