Director, Primary Packaging

Role Overview

• Set and drive best practices within DDSP for primary packaging development.
• Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs.
• Lead primary packaging engineers and scientists to effectively handle commercial biological/drug-device combination product development.
• Guide integration of primary packaging system development with CMC, device development, and Verification and Testing workstreams to influence and enable CSL clinical asset development strategy.
• Ensure container closure system control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance.
• Provide input on behalf of DDSP on aseptic filling processes and controls to CMC as well as external CMOs.
• Create and maintain standard operating procedures, work instructions, and templates for DDSP to use in the development of primary packaging.
• Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of primary packaging and the successful tech transfer to manufacturing sites to enable commercial strategies.
• Provide in-depth technical advice and guidance beyond DDSP department.
• Work with CMC, Operations, and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline.
• Identify and develop talent to meet DDSP business requirements. Plus develop robust succession plans that provide career opportunities for individuals while supporting business resiliency.
• Provide Primary Packaging budget input for projects.
• Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
• Ensure that material science translates into flawless industrial performance by providing mathematical rigor and statistics to move beyond “trial and error” utilizing six sigma principles.

Requirements

• 10+ years of experience in pharmaceutical primary packaging development with hands-on experience in technical review and trade-off discussions.
• Extensive experience within pharmaceutical production, especially aseptic filling and visual inspection.
• Deep knowledge of material properties (e.g., rigid plastics, glass, films), sterilization/ filling methods, and simulation software.
• Proven ability to develop strategies and lead improvement projects.
• Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.
• Previous experience with health authority interactions.
• Intellectual property development experience.
• Certified six sigma black belt.
• Ability to travel internationally for primary packaging design and development projects up to 20%.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL