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To perform analytical 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
Job Responsibility:
Performs experimental work independently in accordance with SOPs on a variety of sample types e.g drug substance and drug product release and stability samples, in-process samples
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 and escalates any issues/delays to the Group Leader and/or scientific lead as appropriate
Liaise with reviewers and study directors to close out technical review of assays.
Interpret data against specifications and identify trends within data
Support, as needed, with the timely completion of investigations, deviations, CAPAs and change controls.
Actively contributes to QC department general lab housekeeping, ensuring the laboratory is adequately stocked with reagents and consumables as needed and may support with the monitoring and maintenance of equipment e.g. IMS
Work collaboratively in a team to ensure business, regulatory and customer needs are met.
Perform other duties as assigned.
Requirements:
HND/BSc in relevant scientific discipline or relevant previous experience (Chemistry / Biochemistry)
Work Experience GMP, Pharmaceutical, Biological Level- Entry Level - 0-4 years
Demonstrates an ability and desire to learn from experience and willing to take on new challenges. Adapts thinking and behaviour to support a culture of process improvements and problem solving. Open to trying new approaches
Seek understanding of the corporate strategy and understands impact of own actions on the business area. Uses knowledge to make accurate and timely decisions
An active member of the team, sharing information and knowledge. Treats all co-workers professionally and with respect
Understand the need of the internal Customer to deliver and takes action to enhance the satisfaction of the Customer in line with the role
Takes responsibility for own safety and safety of others and personal choices and behaviours. Seeks feedback to continuously improve and contributes to a positive work environment