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We are seeking to appoint a Senior Vaccine Production Scientist who will be based at the Clinical BioManufacturing Facility (CBF) within the Pandemic Science Institute, Nuffield Department of Medicine. The Clinical BioManufacturing Facility (CBF) at the University of Oxford produces high-quality Investigational Medicinal Products (IMPs) according to the requirements of Good Manufacturing Practice (GMP) to support early-phase clinical trials in the UK and worldwide. The CBF manufactured the first doses of the Oxford AstraZeneca vaccine against Covid-19 for the UK trials and vaccines for Malaria, TB, Zika, Rabies, Plague, Ebola and other diseases that have a global impact. As a Senior Vaccine Production Scientist, you will be part of the Production team, manufacturing IMPs in our suite of GMP cleanrooms which includes buffer/media preparation and upstream, downstream and fill and finish processes. You will oversee and supervise the work of the Production Assistants in the cleanrooms and ensure all cleanroom ancillary activities are completed correctly and in a timely manner. You will assist the Process Development team with technical transfer and process optimisation from pre-GMP into clinical manufacture. Additionally, you will liaise and communicate efficiently with other teams in the CBF and with collaborators and colleagues in other units and departments of the University. It is essential that you are educated to degree level or equivalent, in a relevant subject together with the capability to work in a cleanroom environment. You will have experience working in a regulated environment (e.g. GMP or GLP) and experience in mammalian cell culture, with good aseptic technique. You will have excellent communication skills, both written and oral, and a critical eye for ensuring full compliance to approved processes. Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This position is offered full time on a fixed term contract for 3 years, with possibility of extension and is funded by the Department. Only applications received before 12 midday on Tuesday 29 October 2024 will be considered. Please quote **175524** on all correspondence.
We are seeking to appoint a Senior Vaccine Production Scientist who will be based at the Clinical BioManufacturing Facility (CBF) within the Pandemic Science Institute, Nuffield Department of Medicine. The Clinical BioManufacturing Facility (CBF) at the University of Oxford produces high-quality Investigational Medicinal Products (IMPs) according to the requirements of Good Manufacturing Practice (GMP) to support early-phase clinical trials in the UK and worldwide. The CBF manufactured the first doses of the Oxford AstraZeneca vaccine against Covid-19 for the UK trials and vaccines for Malaria, TB, Zika, Rabies, Plague, Ebola and other diseases that have a global impact. As a Senior Vaccine Production Scientist, you will be part of the Production team, manufacturing IMPs in our suite of GMP cleanrooms which includes buffer/media preparation and upstream, downstream and fill and finish processes. You will oversee and supervise the work of the Production Assistants in the cleanrooms and ensure all cleanroom ancillary activities are completed correctly and in a timely manner. You will assist the Process Development team with technical transfer and process optimisation from pre-GMP into clinical manufacture. Additionally, you will liaise and communicate efficiently with other teams in the CBF and with collaborators and colleagues in other units and departments of the University. It is essential that you are educated to degree level or equivalent, in a relevant subject together with the capability to work in a cleanroom environment. You will have experience working in a regulated environment (e.g. GMP or GLP) and experience in mammalian cell culture, with good aseptic technique. You will have excellent communication skills, both written and oral, and a critical eye for ensuring full compliance to approved processes. Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This position is offered full time on a fixed term contract for 3 years, with possibility of extension and is funded by the Department. Only applications received before 12 midday on Tuesday 29 October 2024 will be considered. Please quote 175524 on all correspondence.
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Grade 6: Salary in range £33,832 - £39,705 per annum. This is inclusive of a pensionable Oxford University Weighting of £1,500 per year (pro rata).
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Pandemic Sciences Institute, New Richard Building, Old Road Campus, Headington, OX3 7JT
Clinical Bio-Manufacturing Facility, Churchill
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Job title Senior Vaccine Production Scientist Division Medical Sciences Department Nuffield Department of Medicine Location Pandemic Sciences Institute, New Richard Building, Old Road Campus, Headington, OX3 7JT Grade and salary Grade 6: Salary in range £33,832 - £39,705 per annum. This is inclusive of a pensionable Oxford University Weighting of £1,500 per year (pro rata). Hours Full time Contract type Fixed-term contract for 3 years, with possibility of extension Funding is provided by the Department Reporting to Ryan Beveridge, GMP Production Manager Vacancy reference 175524 Hybrid working arrangements The successful person will need to work on site for a minimum of 3 days per week About us    What we offer https://hr.admin.ox.ac.uk/staff-benefits  An excellent contributory pension scheme  38 days annual leave  A pensionable Oxford University Weighting allowance of £1,500 per annum (pro rata)  A comprehensive range of childcare services  Family leave schemes  Cycle loan scheme  Discounted bus travel and Season Ticket travel loans  Membership to a variety of social and sports clubs  A welcoming and diverse community University of Oxford - www.ox.ac.uk/about/organisation Nuffield Department of Medicine (NDM) - https://www.ndm.ox.ac.uk Unit - www.psi.ox.ac.uk The role The Clinical BioManufacturing Facility (CBF) is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility, where basic research can be translated into Investigational Medicinal Products (IMPs) for use in clinical trials. The CBF is a small research facility within the Nuffield Department of Medicine, and presently comprises approximately 25 staff. The CBF has manufactured more than 20 novel vaccines for first-in-man studies, as vaccines for infectious disease and cancer therapy and has supported over 60 clinical trials. In April 2020 the CBF produced ChAdOx1 nCoV-19, the UK’s first COVID- 19 vaccine to enter clinical trials. Later acquired by AstraZeneca, millions of doses of this vaccine have now been administered worldwide. The CBF has also recently produced vaccines against Ebola, MERS and Zika. Currently, the CBF is expanding its GMP manufacturing space to cater for the increasing demand for life-saving research, and the expansion is planned to be operational in a new building by the end of 2024. As a Senior Vaccine Production Scientist, you will be part of the Production Team, manufacturing IMPs in our suite of GMP cleanrooms. You will have day-to-day responsibility for ensuring that Upstream, Downstream and Fill and Finish processes are performed to the highest standards and according to pre-determined procedures and timelines under the guidance of the GMP Production Manager. You will also play a role in transferring new upstream and downstream processes for use in manufacturing. You will oversee the work of a small team of Production staff. You will be highly organised, highly motivated with good interpersonal skills. Good communication skills and the ability to work both as part of a team and independently are essential for this role. Responsibilities You will:           Manufacture IMPs according to the principles of EU GMP. This will include buffer/media preparation and upstream, downstream and fill and finish processes. Ensure all cleanroom ancillary activities (environmental monitoring, material sterilisation, cleaning, equipment calibration and servicing) are completed correctly and in a timely manner. Oversee and supervise the work of the Production Assistants in the cleanrooms and to ensure all work is carried out according to pre-determined timelines. Write and maintain Standard Operating Procedures, Production Batch Records and Study Plans and Reports. Complete satisfactorily Quality Management System documentation (CAPAs, Change Controls, Deviations). Liaise and communicate efficiently with other teams in the CBF and with collaborators and colleagues in other units and departments of the University. Assist the Process Development team with technical transfer and process optimisation from pre-GMP into clinical manufacture. Assist other CBF staff and perform other duties commensurate with the grade and level of responsibility. Participate in and support the public engagement and widening access activities of the Department and the University. This is anticipated to be not more than 2 days per year. Undertake mandatory training as required by the University, Division and Department. The specific list of training courses may change from time-to-time, in response to both legal and internal University requirements. 1 Selection criteria Essential           Educated to Degree level or equivalent, in a relevant subject. Capability to work in a cleanroom environment. Experience in working in a regulated environment (e.g. GMP or GLP). Experience in mammalian cell culture, with good aseptic technique. Experience in biological downstream processes such as tangential flow filtration and/or chromatography. Excellent communication skills, both written and oral. Excellent planning, prioritising and organisational skills. Experience in supervising and supporting other team members. A critical eye for ensuring full compliance to approved processes. Computer literate in Microsoft Office programs (Word, Excel and Outlook). Desirable    Experience in working in cleanrooms according to GMP or other regulated agency. Experience in IMP manufacture and in virus handling and culture. Willingness to participate in the out of hours on-call rota, responding to equipment and building alarms if required. 2 Pre-employment screening Standard checks If you are offered the post, the offer will be subject to standard pre-employment checks. You will be asked to provide: proof of your right-to-work in the UK; proof of your identity; and (if we haven’t done so already) we will contact the referees you have nominated. You will also be asked to complete a health declaration so that you can tell us about any health conditions or disabilities for which you may need us to make appropriate adjustments. Please read the candidate notes on the University’s pre-employment screening procedures at: https://www.jobs.ox.ac.uk/pre-employment-checks Hazard-specific / Safety-critical duties This job includes hazards or safety-critical activities. If you are offered the post, you will be asked to complete a health questionnaire which will be assessed by our Occupational Health Service, and the offer of employment will be subject a successful outcome of this assessment. The hazards or safety-critical duties involved are as follows:     Lone Working Regular manual handling Working with category 3b or 4 lasers (laser safety class) Work with any substance which has any of the following pictograms on their MSDS: 3 How to apply Applications are made through our e-recruitment system and you will find all the information you need about how to apply on our Jobs website https://www.jobs.ox.ac.uk/how-to-apply. If you would like to apply, click on the Apply Now button on the ‘Job Details’ page and follow the onscreen instructions to register as a new user or log-in if you have applied previously. As part of your application you will be asked to provide details of two referees and indicate whether we can contact them now. You will be asked to upload a CV and a supporting statement. The supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This may include experience gained in employment, education, or during career breaks (such as time out to care for dependants). Your application will be judged solely on the basis of how you demonstrate that you meet the selection criteria stated in the job description. Please upload all documents as PDF files with your name and the document type in the filename. Please note using a long file name may prevent you from uploading your documents.  http://www.ox.ac.uk/about_the_university/jobs/professionalandmanagement/ All applications must be received by midday UK time on the closing date stated in the online advertisement Information for priority candidates A priority candidate is a University employee who is seeking redeployment because they have been advised that they are at risk of redundancy, or on grounds of ill-health/disability. Priority candidates are issued with a redeployment letter by their employing department(s). If you are a priority candidate, please ensure that you attach your redeployment letter to your application (or email it to the contact address on the advert if the application form used for the vacancy does not allow attachments). If you need help Application FAQs, including technical troubleshooting advice is available at: https://staff.web.ox.ac.uk/recruitment-support-faqs. Non-technical questions about this job should be addressed to the recruiting department directly recruitment@ndm.ox.ac.uk To return to the online application at any stage, please go to: www.recruit.ox.ac.uk. Please note that you will receive an automated email from our online recruitment portal to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. Important information for candidates Data Privacy Please note that any personal data submitted to the University as part of the job application process will be processed in accordance with the GDPR and related UK data protection legislation. For further information, please see the University’s Privacy Notice for Job Applicants at: https://compliance.admin.ox.ac.uk/job-applicant-privacy-policy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/data-protection-policy. 4 The University’s policy on retirement The University operates an Employer Justified Retirement Age (EJRA) for very senior research posts at grade RSIV/D35 and clinical equivalents E62 and E82, which with effect from 1 October 2023 will be 30 September before the 70th birthday. The justification for this is explained at: https://hr.admin.ox.ac.uk/the-ejra. For existing employees on these grades, any employment beyond the retirement age is subject to approval through the procedures: https://hr.admin.ox.ac.uk/the-ejra. There is no normal or fixed age at which staff in posts at other grades have to retire. Staff at these grades may elect to retire in accordance with the rules of the applicable pension scheme, as may be amended from time to time. Equality of opportunity Entry into employment with the University and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. 5
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