Job title: Scientist (QC Product Testing and Stability)
Location: Slough
Contract Length: 12 months
Working Hours: 37.5 hours/week
Pay: 17.96ph
About The Role
The role is predominantly lab based for the execution analytic testing e.g. HPLC (size exclusion, ion exchange etc.), electrophoresis (e.g. CE SDS, icIEF), spectrophotometry and general characteristic analysis (e.g. visual appearance, pH, Osmolality) for the purpose of assessing the quality and stability of therapeutic proteins. All work is expected to be carried out in a safe and compliant manner in accordance with local EHS policies and cGMP guidelines. In addition, some time will be spent technically reviewing other analysts assays, writing stability study protocols and data summary reports, SOP updates, and assisting with quality records.
Key Responsibilities
- Performs experimental work independently in accordance with SOPs and study protocols on a variety of sample types
- Performs work in a safe, compliant manner, ensuring training profile is maintained and up to date at all times.
- Plans and completes assigned tasks within the required timeframe. Communicates progress and escalates challenges to Line Manager and/or scientific lead as appropriate.
- Technically review assays against SOPs, protocols and GMP principles and liaise with operators and study directors to close out technical review of assays.
- Interpret data against specifications, critically assess results and identify trends within data, reporting any observations and concerns to QC management, SDs, QC representative in a timely manner.
- Writes stability study protocols, reports, testing summaries etc.
- Act as a mentor and/or trainer to newer or more junior members of the team and provide help and support to team mates.
- Supports improvement projects within the department and encourages best practice and corrects incorrect/bad practice.
- Support, as needed, with the timely completion of investigations, deviations, CAPAs and change controls and may independently lead and complete minor investigations e.g. pipette calibration failure, storage equipment temperature excursions.
- Actively contributes to QC department general lab housekeeping, ensuring the laboratory is adequately stocked with reagents and consumables as needed. In addition, perform monitoring and maintenance of equipment and may take on system owner responsibilities.
- Work collaboratively in a team to ensure business, regulatory and customer needs are met.
- Perform other duties as assigned.
Education/Experience Required
- BSc in relevant scientific discipline or relevant previous experience - Chemistry / Biochemistry
- Experience - GMP, Pharmaceutical, Biological
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