Analytical Operations Scientist

GSKKing of Prussia, PA

About The Position

At GSK, we are ambitious for patients. As the healthcare landscape continues to evolve—bringing new stakeholders, data sources, and expectations—we are committed to ensuring that the patient voice meaningfully informs how medicines are developed, evaluated, launched, and delivered to patients. This includes patient engagement across drug development, regulatory decision‑making, health technology assessment, launch planning, and patient care. This role is responsible for the manufacture of biopharmaceutical analytical reference materials and supports the R&D biopharmaceutical critical reagents program in line with regulatory and business requirements. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage the manufacture of analytical reference materials using automated and manual filling instrumentation. Collaborate with GSK R&D and GSC analytical groups to manage manufacturing details and scheduling for reference material and reagent fills. Record and archive manufacturing details to comply with GSK and regulatory requirements. Maintain instrument and inventory of materials required to perform filling operations. Contribute to GSK’s overall critical reagent strategy for biopharmaceutical projects. Shipping and receiving biopharmaceutical critical reagents and RM to support R&D, commercial, and contract testing labs. Actively prepare and support internal quality and external regulatory inspections. Support DDS Leadership by actively participating in the activities and initiatives that promote an organizational culture aligned with GSK Values and Expectations. Adopt data and digital tools to drive continuous improvement and deliver simplified, efficient business processes. Support large molecule stability team with stability protocol and data management, as needed.

Requirements

  • Bachelor of Science in Chemistry, Biology, or a related scientific discipline and 2+ years of experience in a directly related discipline.
  • 2+ years of experience in a project team or directly related discipline

Nice To Haves

  • Experience in operation of automated liquid systems, e.g. Hamilton.
  • Awareness of protein stability and assays used for detection such as CGE, cIEF, HPLC, and functional assays.
  • Awareness of cGMP and Regulatory requirements for the development and commercialization of Biopharmaceuticals.
  • Excellent written and verbal communication skills.
  • Excellent organization skills and ability to handle multiple priorities.

Responsibilities

  • Manage the manufacture of analytical reference materials using automated and manual filling instrumentation.
  • Collaborate with GSK R&D and GSC analytical groups to manage manufacturing details and scheduling for reference material and reagent fills.
  • Record and archive manufacturing details to comply with GSK and regulatory requirements.
  • Maintain instrument and inventory of materials required to perform filling operations.
  • Contribute to GSK’s overall critical reagent strategy for biopharmaceutical projects.
  • Shipping and receiving biopharmaceutical critical reagents and RM to support R&D, commercial, and contract testing labs.
  • Actively prepare and support internal quality and external regulatory inspections.
  • Support DDS Leadership by actively participating in the activities and initiatives that promote an organizational culture aligned with GSK Values and Expectations.
  • Adopt data and digital tools to drive continuous improvement and deliver simplified, efficient business processes.
  • Support large molecule stability team with stability protocol and data management, as needed.
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