Associate Director Packaging Development
Gilead Sciences
August 10, 2026
On-site
San Francisco Bay Area
Operations
Job Description (Associate Director, Packaging Development)
- Provide technical leadership for packaging development, qualification, and commercialization activities for combination products.
- Serve as SME defining packaging strategies to support regulatory submissions and commercialization.
- Define combination product packaging processes; establish governance and operating framework for Packaging Engineering across the combination product ecosystem.
- Drive cross-functional alignment and resolution of complex technical/organizational issues.
- Independently lead packaging development programs across multiple product modalities; may be accountable for development, qualification, and commercialization supporting biologics and OSD based on priorities.
Key Responsibilities
- Strategy & Governance: build/integrate packaging development processes; establish governance/decision-making and interfaces across Packaging Eng., Device Eng., Device Quality, Regulatory Affairs, etc.; define/improve operating model/workflows/best practices.
- Technical Leadership: resolve complex issues; lead during design reviews, risk assessments, change management, governance forums; lead/support design control and hazard/risk assessments.
- Program Execution: lead packaging development/qualification/commercialization; assess manufacturing networks and capability gaps; evaluate/select materials/components/equipment/technologies; identify/evaluate/manage CMOs and external advisors.
- Cross-Functional Integration: collaborate with Human Factors/Human-Centered Design; interact with cross-functional teams; communicate goals/results.
- Documentation & Continuous Improvement: author technical documents/standards and regulatory submission sections; mentor engineers; drive standardization.
Knowledge/Skills (Required/Preferred)
- Required: packaging engineering knowledge; experience leading combination product packaging development programs; cGMP experience; strong design controls, risk/change control; ability to influence in a matrixed organization.
- Preferred/Desirable: biologics packaging systems, shipping/distribution strategies, cold chain packaging; experience with combination product development teams; governance/operating model establishment; traditional pharmaceutical packaging (e.g., OSD); NDA/BLA submission experience; CMOs; computer/organizational/project management skills.
- Working knowledge of regulations/standards (FDA, EU MDR, ISO 11607/14971, 21 CFR 210/211/820, ASTM/ISTA).
Basic Qualifications
- BS in packaging/engineering (or related) + 10+ years relevant industry experience (advanced degrees considered).
Benefits/Compensation
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
- Provide technical leadership for packaging development, qualification, and commercialization activities for combination products.
- Serve as SME defining packaging strategies to support regulatory submissions and commercialization.
- Define combination product packaging processes; establish governance and operating framework for Packaging Engineering across the combination product ecosystem.
- Drive cross-functional alignment and resolution of complex technical/organizational issues.
- Independently lead packaging development programs across multiple product modalities; may be accountable for development, qualification, and commercialization supporting biologics and OSD based on priorities.
Key Responsibilities
- Strategy & Governance: build/integrate packaging development processes; establish governance/decision-making and interfaces across Packaging Eng., Device Eng., Device Quality, Regulatory Affairs, etc.; define/improve operating model/workflows/best practices.
- Technical Leadership: resolve complex issues; lead during design reviews, risk assessments, change management, governance forums; lead/support design control and hazard/risk assessments.
- Program Execution: lead packaging development/qualification/commercialization; assess manufacturing networks and capability gaps; evaluate/select materials/components/equipment/technologies; identify/evaluate/manage CMOs and external advisors.
- Cross-Functional Integration: collaborate with Human Factors/Human-Centered Design; interact with cross-functional teams; communicate goals/results.
- Documentation & Continuous Improvement: author technical documents/standards and regulatory submission sections; mentor engineers; drive standardization.
Knowledge/Skills (Required/Preferred)
- Required: packaging engineering knowledge; experience leading combination product packaging development programs; cGMP experience; strong design controls, risk/change control; ability to influence in a matrixed organization.
- Preferred/Desirable: biologics packaging systems, shipping/distribution strategies, cold chain packaging; experience with combination product development teams; governance/operating model establishment; traditional pharmaceutical packaging (e.g., OSD); NDA/BLA submission experience; CMOs; computer/organizational/project management skills.
- Working knowledge of regulations/standards (FDA, EU MDR, ISO 11607/14971, 21 CFR 210/211/820, ASTM/ISTA).
Basic Qualifications
- BS in packaging/engineering (or related) + 10+ years relevant industry experience (advanced degrees considered).
Benefits/Compensation
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.