Development Scientist (Packaging)
Rates: 21.50p/h PAYE
To provide packaging support to the MDS project teams, Clinical Supply Chain, and Global Supply Chain network.
• Development requirements to support qualification, registration, and launch key events are met. Activities include, but are not limited to:
• Recommend primary packaging components
• Complete primary packaging specifications and testing
• Support/complete stability packaging campaigns
• Complete (generate or review) IND or CTX Container Closure sections with supporting documentation
• Author design control documentation
• Support review of post launch primary packaging changes or stability issues, as needed or requested.
• Assessment of new materials, components, and technologies for both technical performance and cost effectiveness
• Support the development of strategies on package development and technology across the MDS, MPD, GSC, Commercial, and external interfaces to ensure effective Product Development Support:
• Globally harmonized and coordinated strategies for pack development activities
• Incorporate Inclusive Design considerations where appropriate
• Industry and global developments in packaging, and their adoption to support NPS
• Support the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development:
• CMC regulatory strategy on packaging, especially the primary packaging
• Guidance and cross project support to Regulatory, Quality, and GSC
• Input into Group Quality Policies
• Environmental policy and strategy
• B.S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience, with preferably 1-3 years experience in parenteral package development, primarily in pharmaceutical industry.
• Understanding of design control requirements associated with Medical Devices and Combination Products (Drug / Device combinations)
• Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, NPI, and technology transfer processes.
• Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
• Demonstrated ability to accomplish delivery of projects, meet project milestones, and support multiple projects.
• Working knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within MDS and GSC.
• Demonstrated knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.