Development Scientist (R&D)SRG are working with a global name in the field of biotechnology to help them find a Development (R&D) Scientist to join their...
Packaging Development Scientist Location: Ware - Hertfordshire Contract length: 12 months
SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for a Packaging Development Scientist to provide packaging support to the PD project teams, CTS and Global Manufacturing Supply network.
- Recommend primary packaging components
- Complete primary packaging specifications and testing such as: vacuum testing, moisture vapour transmission rate (MVTR), container qualification testing, device testing
- Manage/complete stability packaging campaigns
- Complete (generate or review) IND/NDA CTX/MAA Container
- Closure sections with supporting documentation
- Review of post launch primary packaging changes or stability issues, as needed or requested.
- Cost effective package development.
- Input/support to ensure cost effective solutions (i.e., material selection and process)
- Assessment of new materials, components, and technologies for both technical performance and cost effectiveness.
- Support the development and execution of Global
- Manufacturing Supply Procurement strategies and sourcing groups
- 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 GMS
- B.S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience, with minimum 1 year experience in package development
- Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, NPS, 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 manage 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 PD and GMS.
- 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.
To apply for this position, please email a copy of your CV
For more information regarding this position or any others, please call Umul on 0203 096 4529
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.