GSK·11 days ago
11 days ago
Principal Scientist, Drug Product Steriles Primary Packaging
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What you'll do
- Provide packaging support for drug product steriles, focusing on primary packaging development and compliance
- Support qualification and launch events
- Author regulatory documentation
What they're looking for
- Significant experience in packaging solutions and regulatory standards within pharmaceutical or medical device environments
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Seeking a Principal Scientist to provide packaging support for drug product steriles, focusing on primary packaging development and compliance. Key responsibilities include supporting qualification and launch events, and authoring regulatory documentation. Ideal candidates will have significant experience in packaging solutions and regulatory standards within pharmaceutical or medical device environments.
Skills
- sterile pharmaceutical packaging
- product development
- regulatory compliance
- design verification and validation
- container closure systems
- assay development
- product strategies
- quality by design
- pharmacokinetics
- pharmaceutical formulations
- drug delivery
- stability testing
- product management
- medical device evaluation
- regulatory filings
- product design
- external manufacturing
- technology transfer
- product planning
- molecular modeling
- design control documentation
- ind/nda ctx/maa container closure
- product strategy
- collaboration
Company
GSK
Collegeville, United States of America
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