Associate Director Packaging Development

Gilead Sciences•Foster City, CA

18h•Onsite

About The Position

The Associate Director, Packaging Development is a senior-level individual contributor within the Packaging Development organization, responsible for providing technical leadership for packaging development, qualification, and commercialization activities for combination products. This 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 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.

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.