Steriles Packaging Senior Scientist, Packaging Development & Design

We are building a state-of-the-art end to end externally focused strategic development group which delivers efficient discovery of molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us!

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Are you inspired by user centered packaging and device solutions to meet the challenges of delivering life changing medicines to patients? If so, this Packaging Development opportunity could be an exciting opportunity to consider.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• Recommend primary packaging components
• Complete primary packaging specifications and testing
• Manage/complete stability packaging campaigns
• Complete (generate or review) IND/NDA CTX/MAA Container Closure sections with supporting documentation
• Author design control documentation
• Oversight of design verification and validation testing
• 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 strategy and technological solutions across the Drug Product Development, Project Management , Commercial, Global Supply Chain (GSC), and external interfaces to ensure effective Packaging Development delivery:
• Implement globally harmonized and coordinated strategies for pack development activities
• Produce packaging input to lean manufacture/finished packaging
• Provide competitive advantage through packaging solutions
• Integrate industry and global developments in packaging, and their adoption to support NPIs
• Assessment of external partnering and collaborations
• Support the development and implement the execution of GSC Procurement strategies and sourcing groups
• Guide CMC regulatory strategy on packaging, especially the primary packaging
• Influence environmental policy and strategy for packaging sustainability

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• B.S. degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, with +1 years’ experience in parenteral package development

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• M.S. degree
• 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 ability in delivering projects, working within a complex, multidisciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
• Knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within R&D and GSC.
• 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.

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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