Packaging development Scientist

Thermo Fisher ScientificCollegeville, PA
254dHybrid

About The Position

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. The position is focused on Steriles Packaging Development & Design, specifically as a Scientist in Lab Analysis. The work is primarily aimed at offering support for a multitude of projects related to Steriles ViiV projects in development at GSK.

Requirements

  • Bachelor's degree in Packaging Engineering, Packaging Science, Chemistry, Life Science.
  • 3+ years' experience in parenteral package development, primarily in the pharmaceutical industry.
  • Analytical and/or lab-based experience in the pharmaceutical industry.

Nice To Haves

  • 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.

Responsibilities

  • 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.
  • Conduct analytical techniques including 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.
  • Writing work instructions and contributing to study protocols.
  • Authoring/revising component specifications.
  • Supporting document and knowledge management.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Computer and Electronic Product Manufacturing

Education Level

Bachelor's degree

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