"Alerted.org

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:

+ Scientist

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.