Lims Operational Manager
6 days ago
**Introduction to the role**:
**_“_ The Research & Evaluation department, based at UKHSA Porton, is the UK’s largest capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesisand undertake pre-clinical development and clinical assessment of new vaccines and therapeutics. The capability is also used to undertake studies in microbiological aerobiology, decontamination and detection, and to develop diagnostic & serological assaysfor clinical use. Studies are focused on high priority activities including:Monkeypox, SARS-CoV-2, Ebola, Zika, Crimean Congo Haemorrhagic Fever, Q Fever, Anthrax, Melioidosis, _Clostridium difficile_-Associated Disease, Tuberculosis, Influenza, Pertussis, Meningococcal disease, Group B Streptococcal disease, Legionnaires Disease, Healthcare Acquired Infections, Anti-Microbial Resistance, etc.**
**The Medical Interventions Group’s clinical vaccine assessment activities are based at UKHSA Porton and occupy new world-class research facilities currently dedicated to the development and testing of new COVID-19 vaccines. Research undertaken includesclinical testing to support regulatory licensing of new COVID-19 vaccines and research to inform government decisions on vaccination policies. Home to ground-breaking new technology vital to tackling both COVID-19 and a broad range of emerging health securitythreats, the facility houses new equipment which will improve the speed and capacity to evaluate COVID-19 vaccines and the potential risks from Variants of Concern_.”_**
**Location**
This role will be based at Porton Down, Salisbury
- *Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*_
**Working Pattern -**Full Time, Part Time, Job Share, Flexible Working,
**As the LIMS operational Manager your main responsibilities will include**:
The job holder will be required to carry out the following responsibilities, activities and duties:
- Taking a lead role in the project to implement and support the validation of a LIMS for a high throughput, regulated facility.
- Configuring Laboratory Information Management System (LIMS), validation rules, calculations, auto completions, implementing workflows, and overall support of LIMS.
- Ensuring that the LIMS is implemented and maintained in compliance with GCP regulations, with input from computer systems validation (CSV) and Quality Assurance (QA)
- Carrying out management and maintenance actions as recommended by the LIMS provider and Internal Standard Operating Procedures (SOPs) to maintain system integrity
- Diagnosing hardware and software problems and providing technical support to users in services, installations, and training of LIMS.
- Working with software vendors to troubleshoot issues related to LIMS access or performance; maintaining and repairing LIMS to minimise downtime until solutions are reconciled. Maintaining communication with internal users and stakeholders to ensure appropriatedecisions are made with regards business continuity
- Supporting the integration of the LIMS with internal systems, lab instruments and software
- Working with others to write documentation and manuals. Review LIMS SOPs and amend based on changes to functionality or in line with new developments or system upgrades
- Working with internal stakeholders to analyse requirements, develop implementation, integration and test plans.
- Providing training on all aspects of the daily use of LIMS based on the LIMS SOPs. Provide update training as required on new LIMS functionality
- Seeking feedback on the LIMS system performance through communication with LIMS’ internal laboratory users; using feedback to improve performance.
- Evaluating data generated/stored within the system to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. Further duties/responsibilities can also be found on the full job description. The Job holder is expected to accept reasonable alterations andadditional tasks of a similar level that may be necessary.
**Person Specification**
**We are looking for an exceptional LIMS Operational Manager**
**Essential**:
- Significant working knowledge and experience of LIMS in a high throughput, regulated environment (e.g. GCP, ISO9001)
- Instrument integration experience
- Experience in troubleshooting software and hardware problems and triaging to relevant support colleagues as appropriate
- Problem solving skills, strategic thinking and the ability to respond to sudden unexpected demands
- Demonstrated capability to plan over short, medium and long-term timeframes and adjust plans and resource requirements accordingly
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