Investigator, Packaging Design Steriles
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: May 27 2020
As an Investigator you will be responsible for providing packaging support to the PDS project teams, CTS, and Global Manufacturing Supply 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
- 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 strategies on package development and technology across the PDS, MPD, GMS, 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
- Packaging input to lean manufacture/packaging • Providing competitive advantage through packaging
- Industry and global developments in packaging, and their adoption to support NPS
- Assessment of external partnering and collaborations
- 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
- 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 minimum 1-3 year experience in parenteral package development, primarily in pharmaceutical industry.
- 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, multidisciplinary 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 PDS 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.
- Understanding of design control requirements associated with Medical Devices and Combination Products (Drug / Device combinations)
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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