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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