SRG are currently looking for a Development Scientist for a Global Pharmaceutical Company who have opened a new vacancy within their team.
SRG are currently looking for a Development Scientist for a Global Pharmaceutical Company who have opened a new vacancy within their team on an initial 12 Month basis to be based at their office in Ware.
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
- 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 harmonised 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
- S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience, preferably with experience in parenteral package development.
- Understanding of design control requirements associated with Medical Devices and Combination Products.
- 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 organisation and matrix teams.
- Demonstrated ability to support multiple projects and accomplish delivery and meet project milestones.
- 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.
- Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
Carbon60, Lorien, SRG - the Impellam Group STEM Portfolio is acting as an Employment Business in relation to this vacancy.
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