CVIM GMP Facility Lead
2 days ago
Pirbright
The Pirbright Institute delivers world-leading research to understand, predict, detect and respond to viral disease outbreaks. We study viruses of livestock that are endemic and exotic to the UK, including zoonotic viruses, by using the most advanced tools and technologies to understand host-pathogen interactions in animals and arthropod vectors. Our major strength in understanding the immune systems of livestock provides a platform to control current diseases and respond to emerging threats. This important research would not be possible without the proportionate use of animals, which are integral to the development of new disease control measures such as vaccines and diagnostics. We have an establishment-wide commitment to the 3Rs (replacement, reduction and refinement), high standards of animal welfare, a culture of care and openness. Our Institute is made up of a dynamic and vibrant community of staff covering a diverse set of chosen fields, backgrounds and experience. We all play a crucial role in furthering the Institute's aspirations, advancing the frontiers of science and knowledge through our excellent scientific research, knowledge sharing and contribution; with a real focus in improving the world in which we live. Our outlook is always balanced by our strong sense of purpose, values and behaviours and an unwavering commitment to a ‘one Institute’ approach. The Centre for Veterinary Vaccine Innovation and Manufacturing ( CVIM )supports the development and deployment of vaccine technologies to combat neglected and emerging diseases of livestock, including zoonotic diseases that represent a threat to public health. CVIMis part of The Pirbright Institute. The CVIM GMP Facility Lead is a strategic role within CVIM which reports directly to the Director of CVIM. They will be overall responsible for the new CVIM GMP Facility working very closely with the CVIM Process Development Team to ensure successful technology transfer from R&D. The role is ideal for someone who can influence strategy alongside having hands-on operational leadership. It provides an opportunity to drive improvements, contribute to establishing GMP processes and enhance CVIM scientific output. Their main purpose is to deliver and optimise production efficiency and facility operations, and lead the CVIM GMP Team whilst managing a highly regulated and fast paced environment. They will be accountable for end-to-end operational performance, overseeing all GMP processes within the facility. • Develop and manage the product and process strategy for the CVIM GMP Facility, aligning plans with CVIM objectives and future growth initiatives working closely with the Director of CVIM, Head of Business Development and the CVIM Process Development Team ., • Establish a cost-effective programme of production and activities for the facility to reduce downtime and ensure maximum use without jeopardising licensing., • Lead and ensure full compliance with cGMP across all operational areas., • Oversee all aspects of production, ensuring products are manufactured, stored and shipped in a compliant manner., • Provide leadership and technical expertise across departments such as process development, facility management, QC, and production., • Facilitate the development and establishment of QC capability., • Drive continuous improvement programs, manage the facility budget, and ensure maximum asset use while maintaining cGMP standards., • Ensure that there are appropriate levels of suitably trained personnel to plan, organise and oversee planned activities., • Ensure that activities are conducted in a timely manner in accordance with an agreed project strategy and maintain effective communication with other relevant departments to ensure activities are planned and co-ordinated effectively e.g. production, formulation development, analytical support/ QC, QA, scheduling, project management, facility management, validation, stores, engineering etc., • Develop a system for GMP facility reporting metrics. Identify and address key improvement opportunities., • Assist in the review and realisation of new opportunities, providing information on the capabilities and limitations of existing process equipment within production., • Maintain an audit ready facility by leading and ensuring cGMP compliance across all functions; QC, facility management and production., • Act as a point of escalation when processing or GMP compliance issues arise., • Lead on issues arising from processing and participate as required in investigation for deviations., • Manage changes through change control ensuring risks are mitigated and impact minimised to GMP and end users., • Participate in and respond to internal and external audits., • Promote effective collaboration between all workstreams., • Contribute to improvements that enhance productivity, compliance, and customer service., • Maintain an inspection readiness, safe, and compliant working environment at all times., • Foster a service-focused, collaborative, and inspection readiness culture within the facility., • Promote effective collaboration with other CVIM teams to enable seamless process transfer. This job description is only an outline of the tasks, responsibilities and outcomes required of the role. The jobholder will carry out any other duties as may be reasonably required by his/her line manager. The job description and personal specification may be reviewed on an ongoing basis in accordance with the changing needs of The Pirbright Institute. • Substantial experience of working in relevant industry to GMP., • Educated to degree level or equivalent in a related discipline., • Strong practical experience of working in cleanrooms to ISO7 and/ or ISO8., • Proven leadership experience of at least 10 years in a high-volume manufacturing facility within the biotech, pharmaceutical, or related sectors., • Extensive knowledge of cGMP standards, EU GMP/MHRA guidelines, and Quality Management Systems., • Excellent interpersonal skills and a demonstrable ability to effectively communicate at various levels within a regulatory framework., • Good attention to detail and ability to work in a structured and systematic manner., • Ability to clearly present data to stakeholders., • Ability to work with minimal supervision independently as well as part of a team., • Ability to train others (e.g., delivering presentations or procedural training)., • Experience of working with a LIMS software programme., • Experience on developing new assays and completing validation to rigid standards. Due to the nature of the work carried out by Pirbright, all successful applicants will be required to go through a comprehensive screening process including reference and qualification checks, financial and security clearances. • A unique opportunity to shape both your research programme and the scientific direction of a world-leading institute., • Beautiful campus in a semi-rural location with free on-site parking and good transport links., • Generous Group Personal Pension Scheme and life assurance (subject to age and earnings)., • Professorial-equivalent appointment (Band H); salary negotiable., • Permanent position with senior leadership responsibilities., • Annual consumables budget, access to internal PhD studentships, internships, and seed funding., • Eligibility for strategic funding for a postdoctoral researcher., • 25 days annual leave plus public and privilege days, increasing up to 31 days with long service., • Enhanced Parental package., • Option to buy and sell annual leave., • Option to carry over or buy up to two weeks' annual leave., • Pirbright Lifestyle Hub (employee discount website)., • Cycle to work scheme., • Childcare allowance., • Electric car charging facilities. This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of skills, efforts, duties, responsibilities, or working conditions associated with it. Responsibilities may change to carry out other duties as may be reasonably required by the line manager and may be reviewed on an ongoing basis in accordance with the changing need of The Pirbright Institute Our commitment to fostering a diverse, inclusive, and sustainable environment that supports cutting-edge research and professional growth. #J-18808-Ljbffr
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