The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures.
A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers).
The main responsibilities for this position include;
• Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.
• Review and approve analytical instrumentation qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification is appropriate to the use of the instrument.
• Manage all instrument specific investigations such as calibration deviations.
• Trend lab instrument performance and lifecycle management.
• Participate in new instrument purchase and qualification
• Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments.
• Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.
• Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
• Participate in definition and establishment of instrument related procedures.
• Participate in troubleshooting complex instrumentation issues.
The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 year’s experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting. Previous experience in technology transfers would be advantageous.
The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate time management and organisational skills and excellent communication is essential.
The United Kingdom (UK) consists of four countries: England, Scotland, Wales, and Northern Ireland. Each of these countries is further divided into counties, cities, boroughs, and districts. Here’s a detailed breakdown:
England
England is divided into nine regions, which are further subdivided into counties and districts. The regions are:
North East England
Counties: Northumberland, Tyne and Wear, County Durham, Tees Valley (part of Durham and North Yorkshire)
North West England
Counties: Cumbria, Lancashire, Greater Manchester, Merseyside, Cheshire
Yorkshire and the Humber
Counties: North Yorkshire, West Yorkshire, South Yorkshire, East Riding of Yorkshire, Lincolnshire (part)
East Midlands
Counties: Derbyshire, Nottinghamshire, Leicestershire, Rutland, Northamptonshire, Lincolnshire (part)
West Midlands
Counties: Shropshire, Staffordshire, West Midlands (county), Worcestershire, Warwickshire, Herefordshire
East of England
Counties: Bedfordshire, Cambridgeshire, Essex, Hertfordshire, Norfolk, Suffolk
London
The capital city, divided into 32 London boroughs and the City of London.
South East England
Counties: Berkshire, Buckinghamshire, East Sussex, Hampshire, Isle of Wight, Kent, Oxfordshire, Surrey, West Sussex
South West England
Counties: Gloucestershire, Bristol, Wiltshire, Somerset, Dorset, Devon, Cornwall, Isles of Scilly
Scotland
Scotland is divided into 32 council areas, often grouped into larger regions:
Highlands and Islands
Council Areas: Highland, Orkney Islands, Shetland Islands, Western Isles, Moray, Argyll and Bute
North East Scotland
Council Areas: Aberdeen City, Aberdeenshire
Tayside
Council Areas: Angus, Dundee City, Perth and Kinross
Central Scotland
Council Areas: Stirling, Falkirk, Clackmannanshire
West Scotland
Council Areas: Glasgow City, East Dunbartonshire, West Dunbartonshire, North Lanarkshire, South Lanarkshire, Renfrewshire, East Renfrewshire, Inverclyde
South West Scotland
Council Areas: Dumfries and Galloway, East Ayrshire, North Ayrshire, South Ayrshire
Lothian
Council Areas: Edinburgh City, West Lothian, Midlothian, East Lothian
Fife
Council Area: Fife
Borders
Council Area: Scottish Borders
Wales
Wales is divided into 22 principal areas (counties, county boroughs, and cities):
North Wales
Principal Areas: Anglesey, Gwynedd, Conwy, Denbighshire, Flintshire, Wrexham
Mid Wales
Principal Areas: Powys, Ceredigion
South West Wales
Principal Areas: Carmarthenshire, Pembrokeshire, Swansea, Neath Port Talbot
South Wales
Principal Areas: Bridgend, Vale of Glamorgan, Rhondda Cynon Taf, Merthyr Tydfil, Cardiff
South East Wales
Principal Areas: Caerphilly, Blaenau Gwent, Torfaen, Monmouthshire, Newport
Northern Ireland
Northern Ireland is divided into 11 districts:
Antrim and Newtownabbey
Ards and North Down
Armagh City, Banbridge, and Craigavon
Belfast
Causeway Coast and Glens
Derry and Strabane
Fermanagh and Omagh
Lisburn and Castlereagh
Mid and East Antrim
Mid Ulster
Newry, Mourne, and Down
Summary
The UK is a union of four distinct countries, each with its own subdivisions, including regions, counties, cities, boroughs, districts, and council areas. This administrative structure supports local governance and helps manage the diverse needs of its regions.
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