Analytical Scientist

Sandoz

Cambridge, United Kingdom

Your Key Responsibilities:

Your responsibilities include, but not limited to:

  • Comply with applicable GxP regulations, SOPs, HSE, ISEC & other Sandoz Guidelines in the laboratory.
  • Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
  • Execute purchase orders (e.g. lab reagents, consumables)
  • Support establishment and maintenance of lab instructions, SOPs, templates.
  • Support cleaning, maintenance, qualification, and calibration of lab / pilot equipment with accompanying documentation.
  • Ensure proper laboratory cleaning, housekeeping, and waste disposal.
  • Stewardship for projects assigned.
  • Execute and document analytical tests for products assigned in the context of process transfer, process improvement and process validation.
  • Launch and transfer for projects assigned.
  • Perform experiments to support root cause investigation based on written protocols.
  • Execute, evaluate, and document experiments according to written protocols, and create tables and graphs to interpret results.
  • Recognize, communicate, address, and solve problems (including OOT and OOS results) within own team and broader are of responsibility.
  • Actively transfer technical know-how to other departments and contractors, including troubleshooting and training.
  • Supports inhalation product development by conducting analytical test packages, including finished product characterization.
  • Support device development by collaborating with device engineering to provide feedback on device changes which influence in vitro results.
  • Support device design proving, design window and design verification in vitro characterisation studies.

Unique responsibilities:

  • Write stability study protocols and reports, and review and trend stability data for combination product development.

What you’ll bring to the role:

Essential Requirements:

  • BSc in Chemistry, Pharmaceutical Sciences or other Life Sciences
  • Experience in Respiratory combination product testing and/or development required
  • Good knowledge of ICH stability guidelines and pharmacopoeia monographs required
  • Experienced in analysis using high-performance liquid chromatography using various detectors.
  • Experience in working to GLP, GMP and ISO13485 quality management systems is required but not essential
  • Data analytic skills required
  • MS Word and PowerPoint at Intermediate level required.

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