We are seeking an experienced Packaging Scientist to provide technical leadership in the selection, development, validation, and lifecycle management of primary packaging materials for parenteral pharmaceutical products.
This role supports both development and commercial products within a global supply chain and product management environment, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities
Serve as subject matter expert for primary packaging components and systems (e.g., glass vials, prefilled syringes, plastic bottles, rubber stoppers, aluminium or plastic caps).
Provide drug product packaging and container closure expertise to support R&D and supply chain development projects.
Lead lifecycle management activities for commercial primary packaging materials, including productivity initiatives, supplier evaluations, component changes, and technology improvements.
Design, develop, and test Container Closure Systems (CCS) to meet required quality, safety, environmental, sustainability, and regulatory standards.
Develop and execute test protocols and generate technical reports to ensure functionality and integrity of packaging systems.
Write and maintain material and component specifications.
Support continuity of supply for marketed products, including troubleshooting manufacturing issues, supporting complaint investigations, and evaluating root causes related to packaging components.
Prepare and review scientific and technical documentation to support regulatory submissions.
Present and defend container closure strategies and development reports to regulatory authorities when required.
Represent the organisation in technical discussions with external suppliers and third parties.
Contribute to continuous improvement initiatives, applying lean principles and best practices within lifecycle management processes.
GMP / Regulatory Responsibilities
Operate in compliance with current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP) standards.
Lead and execute prioritized projects supporting new product introductions (NPI) and commercial products.
Prepare and review GMP documentation for regulatory submissions as subject matter expert.
Write and execute validation and verification protocols.
Conduct and document testing in accordance with GMP requirements.
Complete Container Closure System validation studies