Sr. Engineer, Global Packaging Development, Cold Chain | Genentech | South San Francisco, CA, USA

At Roche, 88,500 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

This position supports the establishment of a world-class packaging organization by providing technical expertise in the development and deployment of new packaging systems for temperature controlled pharmaceutical and combination products. The position is within the Distribution Technology function of Global Packaging Development. The selected candidate will work on a variety of packaging initiatives and will support Distribution Technology in establishing shipping systems for clinical and commercial use. This position will play a role in representing Distribution Technology with European stakeholders in Quality, Regulatory, Operations, and Technical Development Teams. The organization is headquartered out of South San Francisco (SSF) and this position will be based in SSF.

Group Responsibilities:

• Ensure integration of Distribution Technology with Roche Europe through understanding customer needs and leveraging the gPKD organization to provide solutions
• Manage engineering life cycle for global shipping methods
• Develop and qualify shipping methods for temperature sensitive products
• Support global teams in achieving business, quality and regulatory goals
• Develop and test dangerous goods shipping systems
• Scope:
  • Drug Substance and Drug Product
  • Clinical and Commercial

Technical Requirements:

• Design and implementation of new shipping methods and technologies
• Plan, execute and document shipping qualifications
• Familiar with regulatory expectations for drug and device distribution
• Contribute to shipping validation section of regulatory submissions
• Understand industry best practices in engineering temperature controlled shipping methods
• Technical risk assessment, e.g. FMEA for shipping methods
• Project management
• Develop component and material specifications
• Failure analysis
• Design of experiments (DOE)
• Collaborative Requirements:
• Participate on technical development teams, product supply chain teams, Roche internal and external committees and working groups
• Skilled in managing cross-functional projects
• Able to provide and receive candid feedback
• Alignment of activities with other gPKD initiatives
• Drive towards optimization and standardization of packaging components
• Participate in industry collaboration through conferences, workshops, etc.
• Provide technical support to internal customers including Operations, Regulatory, and Quality
• Transfer of packaging items/solutions into commercial facilities

Who You Are

Requirements:

• Bachelor degree or higher in materials science, mechanical, chemical or packaging engineering
• At least 5 years experience in relevant field
• Knowledge of temperature controlled shipping processes and test methods
• Knowledge of packaging test methods for parenteral and solid oral dosage drugs
• Knowledge of industry best practices
• Proficient technical leadership, collaboration and communication skills
• Proficient in MS Office Suite including MS Project
• Knowledge of statistical methods and software
• English language proficiency required, knowledge of German an asset

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