Job Title: Analytical Testing Coordinator
Location: Porton Down, Wiltshire
Salary: Circa £27k
Education Required: Degree Level in a Relevant subject
Our client has approximately 280 staff, performing a range of process and analytical development, production, quality control and quality assurance roles associated with the development and manufacture of biopharmaceuticals.
Within the Development Group, the Method Development team is responsible for developing and performing analytical methods to support the manufacture of biopharmaceutical products. The methods are used to characterise existing manufacturing processes, to guide process improvements and to support the introduction of new processes. We are seeking an Analytical Testing Coordinator to organise and oversee the testing of samples supplied by other groups within the Development Group and by the manufacturing department.
The successful applicant will coordinate the activities of a team of analysts using established test methods and will be responsible for ensuring that incoming samples are tested in a timely manner and to an appropriate standard of quality. He or she will actively review data as it is generated and monitor the performance of all analytical techniques used routinely in developmental studies by trending key parameters.
Education at least to degree level in a relevant subject is essential, as is experience of performing analytical tests in a regulated environment including hands-on use of HPLC or UPLC for analysing proteins. Experience of preparing technical documentation such as standard operating procedures, protocols and reports is also essential. Other desirable experience includes: leading a team working on multiple projects; setting up and monitoring stability studies; maintaining and improving a database; development, transfer and/or troubleshooting analytical methods; preparation of user requirement specifications for new equipment; liaising with external testing laboratories; use of Empower software. The post holder must have excellent organisational skills, be able to communicate effectively and will be expected to take the initiative when issues arise. An up-to-date knowledge of ICH guidelines and other regulatory requirements relating to analytical methods would be an advantage.
Duties & Responsibilities
- Liaising with the individuals and departments who send samples to be tested
- Advising on study design when analytical input is requested
- Maintaining a list/database of samples, tests required and test status
- Continually improving the sample planning and tracking system
- Organising and tracking stability studies
- Coordinating the testing of samples within a group of analysts, ensuring that testing and reporting of results occur in a timely manner
- Ensuring that appropriate equipment, consumables and reagents are available at all times
- Hands-on testing of samples as required
- Troubleshooting minor issues of instrument or method performance
- Checking results from other operators (especially HPLC / UPLC chromatograms from protein analysis)
- Monitoring and trending key test parameters and identifying any issues that arise
- Aiding in investigations of method performance and redevelopment / requalification if needed
- Helping with method transfer from the development phase to routine use or from the
- Development Group to QC
- Organising testing at external laboratories and shipment of materials
- Taking responsibility for the supervision and training of junior staff where appropriate.
- Taking responsibility for the supervision of laboratory facilities as directed.
- Performing any other duties required by the Line Manager commensurate with grade.
- Ensuring that project teams undertake work in accordance with the company’s Code of Safety Practice and the ISO 9001 Quality Standard.
- Maintaining awareness of Industry and International Regulatory Standards or GxPs
- and implementing where appropriate.
- Complying with all company policies and procedures.