Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Steriles Packaging Development & Design - SOW Scientist: Lab Analysis
The role is to be based at GSK's R&D site in Upper Providence, Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may also be required
Grade:
Essential Qualifications:
- Bachelor's degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, with 3+ years' experience in parenteral package development, primarily in pharmaceutical industry
- Analytical and/or lab-based experience in the pharmaceutical industry
Preferred Qualifications:
- Knowledge of parenteral packaging materials, components, vendors, analytical equipment, and technologies.
- Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations.
- 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.
- Ability to quickly establish relationships with internal and external stakeholders.
- Strong time management / organizational skills.
- Evidence of team working skills and flexibility.
Work Summary: To provide packaging and early device feasibility development analytical support in the UP, PA site.
The task list outlined below provides a comprehensive summary of the crucial work that needs to be carried out in the Steriles Packaging Development and Early Device-ability lab/team. This work is primarily aimed at offering support for a multitude of projects related to Steriles ViiV projects in development at GSK.
Tasks:
- Perform timely execution of lab-based analysis, including timely experiment write-up to support sterile primary package selection, integrity, stability, and lifecycle for the coordination and testing of samples
- Examples of analytical technique include extrusion force testing, stopper movement assessment, CCI capabilities including HeLD, Vacuum Decay, and headspace analysis
- Be a practical expert in a packaging/analytical technique relevant to a primary pack presentation, capable of training others in the technique and application
- Collaborate with the Lab Manager to maintain the License To Operate (LTO) status in the Lab - including equipment maintenance, documentation and coordination with vendors, management monitoring, and safety requirements
- Maintain packaging lab component and lab inventory, including ordering, receiving, and organization of lab space to enable dynamic, flexible laboratory workspace
- Prepare and communicate data summaries to relevant project team members
- Conduct early-stage device feasibility testing as directed
Stretch Tasks:
- Writing work instructions, study protocol contribution
- Authoring/revising component specifications
- Supporting document and knowledge management
