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Clinical Bio-Manufacturing Facility, Churchill
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Wellcome Trust Centre Clinical Vaccinology and Tropical Medicine
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172046 - Quality Control Assay Development Sepcialist - JD
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We are seeking to appoint a Quality Control Assay Development Specialist to join our team at the Clinical BioManufacturing Facility (CBF) in the Nuffield Department of Medicine, to assist us in our mission to improve global health. 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 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. We 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. You will have a hands-on role in the development and adoption of analytical techniques for new IMP projects coming into the CBF, and for modernising our existing QC testing portfolio. You will be working with external clients and the CBF’s Pre-GMP and QC teams to transfer analytical assays to the CBF and with the development and use of new assays at the technology transfer stage, ensuring compliance with appropriate regulations such as the European Pharmacopoeia (Ph. Eur.). You will liaise with and guide potential clients at early stages of manufacturing process development to ensure product assays are suitable for eventual GMP compliant use. In addition, you will write appropriate Reports, Risk Assessments and Standard Operating Procedures to enable the implementation of improved and new analytical assays. It is essential that you hold a degree in a relevant biological/biomedical subject. You will be technically adept and experienced at laboratory techniques and assays including standard molecular biology techniques, and you will have experience in assay development. Additionally, you will be able to analyse and present scientific data, liaise with other scientists, write up and present research proposals and results, and represent the QC group at meetings, internally and with external clients. Experience of working in a GMP environment would be highly desirable. 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 and is funded by the Department. Only applications received before 12 midday on 26 June 2024 will be considered. Please quote 172046 on all correspondence.
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Nuffield Department of Clinical Medicine
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We are seeking to appoint a Quality Control Assay Development Specialist to join our team at the Clinical BioManufacturing Facility (CBF) in the Nuffield Department of Medicine, to assist us in our mission to improve global health. 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 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. We 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. You will have a hands-on role in the development and adoption of analytical techniques for new IMP projects coming into the CBF, and for modernising our existing QC testing portfolio. You will be working with external clients and the CBF’s Pre-GMP and QC teams to transfer analytical assays to the CBF and with the development and use of new assays at the technology transfer stage, ensuring compliance with appropriate regulations such as the European Pharmacopoeia (Ph. Eur.). You will liaise with and guide potential clients at early stages of manufacturing process development to ensure product assays are suitable for eventual GMP compliant use. In addition, you will write appropriate Reports, Risk Assessments and Standard Operating Procedures to enable the implementation of improved and new analytical assays. It is essential that you hold a degree in a relevant biological/biomedical subject. You will be technically adept and experienced at laboratory techniques and assays including standard molecular biology techniques, and you will have experience in assay development. Additionally, you will be able to analyse and present scientific data, liaise with other scientists, write up and present research proposals and results, and represent the QC group at meetings, internally and with external clients. Experience of working in a GMP environment would be highly desirable. 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 and is funded by the Department. Only applications received before 12 midday on 26 June 2024 will be considered. Please quote **172046** on all correspondence.
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Henry Wellcome Building of Cellular and Molecular Physiology
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Job title Quality Control Assay Development Specialist Division Medical Sciences Department Nuffield Department of Medicine Location Pandemic Sciences Institute, Clinical BioManufacturing Facility, Churchill Drive, Headington, Oxford, OX3 7JT Grade and salary Grade 7: Salary in range £36,024 - £41,732 per annum Hours Full time Contract type Fixed-term contract for 3 years, in the first instance Funding is provided by the Department Reporting to Pre-GMP Manager, with day-to-day technical supervision from the QC Manager Vacancy reference 172046 Additional information This role meets the eligibility requirements for a Skilled Worker Certificate of Sponsorship or a Global Talent Visa under UK Visas and Immigration legislation. Therefore, the Nuffield Department of Medicine welcomes applications from international applicants who require a visa. About us • • • What we offer https://hr.admin.ox.ac.uk/staff-benefits • An excellent contributory pension scheme • 38 days annual leave • 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 - https://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 28 staff. The CBF has manufactured more than 30 novel products for first-in-man studies, as vaccines for infectious disease and cancer therapy and has supported over 100 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, billions of doses of this vaccine have now been administered worldwide. We have also supported Oxford’s malaria vaccine development program and other major projects for outbreak and pandemic responses. We are seeking an experienced research scientist to support our Quality Control (QC) group. You will have a hands-on role in the development and adoption of analytical techniques for new IMP projects coming into the CBF, and for modernising our existing QC testing portfolio. You will also be responsible for the validation of new equipment, and will assist the QC group in delivering QC testing and other GMP activities for the CBF’s full range of IMPs. Responsibilities You will: • • • • • • • • • • • • Liaise with and guide potential clients at early stages of manufacturing process development to ensure product assays are suitable for eventual GMP compliant use. Manage own academic research and administrative activities. This involves small scale project management, to co-ordinate multiple aspects of work to meet deadlines. Work with external clients and the CBF’s QC team to transfer analytical assays to the CBF, ensuring compliance with appropriate regulations such as the European Pharmacopoeia (Ph. Eur.). Introduce and validate specialist scientific equipment into the CBF’s GMP environment. Provide training to CBF team members on using new equipment and performing analytical assays. Write appropriate Reports, Risk Assessments and Standard Operating Procedures to enable the implementation of improved and new analytical assays. Support the CBF Pre-GMP team with the development and use of new assays at the technology transfer stage. Support the QC team in testing when required. Contribute ideas for new research and analytical development projects. Operate at all times within the CBF’s Quality Management System. 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 • • • • • • • • Hold a degree in a relevant biological/biomedical subject. Technically adept and experienced at laboratory techniques and assays including standard molecular biology techniques. Experience in assay development. Experience of working in a QC team. Experience in handling viruses and /or GMOs. Ability to analyse and present scientific data, liaise with other scientists, write up and present research proposals and results, and represent the QC group at meetings, internally and with external clients. Ability to manage own workload, including time management and prioritisation skills. High attention to detail with the ability to document all work accurately and clearly. Desirable • • • • • • • Up-to-date knowledge of relevant sections of the Ph. Eur, and GMP guidelines. Hold a PhD/DPhil (or close to completion) in the biological sciences. Experience of working in a GMP environment. Experience in NGS, ELISA and FACS assays. Experience in the analysis of diverse biological materials. Experience in writing reports and Standard Operating Procedures. Experience in Validation documentation, including Design Qualification, User Requirement Specifications, etc. 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: • Work with any substance which has any of the following pictograms on their MSDS: 2 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/research/ 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. The University’s policy on retirement 3 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. 4
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Grade 7: Salary in range £36,024 - £41,732 per annum
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Pandemic Sciences Institute, Clinical BioManufacturing Facility, Churchill Drive, Headington, Oxford, OX3 7JT
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