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We are seeking to appoint a Senior Quality Control Scientist to join our team at The Clinical BioManufacturing Facility (CBF). The 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. You will be based within the Quality Control department, under the supervision of the QC Manager, and responsible for the hands-on day-to-day running of the QC Laboratory, together with other Quality Control staff. You will be responsible for carrying out all work according to the regulatory guidelines of 'Good Manufacturing Practice' as defined in current version of the MHRA `Rules and Guidance for Pharmaceutical Manufacturers and Distributors', also known as the Orange Guide. You will be tasked with supervising the work of junior staff of the QC Department and training other CBF members in relevant SOP as required. You will be a point of contact for receipt, logging and scheduling of In-Process samples testing and will co- ordinate the stability study and clinical re-test schedule to ensure all testing is completed within the specified timeframe. You will also be responsible for carrying out general laboratory housekeeping, ensuring tidiness, cleanliness and safe operation as well as, carrying out QC sampling of new batches of chemicals and materials. It is essential that you hold a Bachelor of Sciences degree in biology/biochemistry with laboratory experience. You will have a high-level of practical skills and theoretical knowledge of standard molecular biology techniques and cell culture, as well as the ability to design and implement validation experiments. You will be conscientious, well-organised and motivated with the ability to work independently and work as part of a cross functional team and have the ability to communicate and develop effective working relationships with a wide range of staff at all levels, internally and externally. 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 Monday 8 April 2024 will be considered. Please quote **170224 **on all correspondence.
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Description of Senior Quality Control Scientist
Clinical Bio-Manufacturing Facility, Churchill
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Job title Senior Quality Control Scientist Division Medical Sciences Department Nuffield Department of Medicine Location Pandemic Science Institute, Clinical Biomanufacturing Facility, Churchill Drive, Headington, Oxford OX3 7JT Grade and salary Grade 6: salary in range £32,332 - £38,205 per annum Hours Full time Contract type Fixed-term contract for 3 years Funding is provided by the Department Reporting to Daniela Moralli, QC Manager Vacancy reference 170224 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 - www.psi.ox.ac.uk The role You will be based within the Quality Control department, under the supervision of the QC Manager, and responsible for the hands-on day-to-day running of the QC Laboratory. Your work will be performed in accordance of Good Manufacturing Practice (GMP) and therefore excellent literacy, numeracy, verbal and written communication skills and an eye for detail are imperative. Activities will include routine and batch release QC testing of different products, (for example adenoviral vectors, virus like particles and recombinant proteins), environmental monitoring and playing a leading role in QC equipment maintenance and calibration/qualification activities. This is an important role within the CBF ensuring that our novel vaccines and advanced therapy medicinal products meet their product specification and are safe to use in patients and clinical trial volunteers. Responsibilities You will: General Activities • • • • • • • • • • • • • • • • • • • Independently carry out all work according to the regulatory guidelines of 'Good Manufacturing Practice' as defined in current version of the MHRA `Rules and Guidance for Pharmaceutical Manufacturers and Distributors', also known as the Orange Guide. Independently carry out QC tests including immunostaining, spectrophotometry, PCR, pH, bioburden, endotoxin. Independently supervise the work of junior staff of the QC Department. Train other CBF members in relevant SOP as required. Follow written procedures and complete appropriate documentation according to the CBF ‘Good Documentation Practice’ guidelines. Assess, identify and correct issues affecting the smooth running of the QC lab. Be a point of contact for receipt, logging and scheduling of In-Process samples testing. Co-ordinate the stability study and clinical re-test schedule to ensure all testing is completed within the specified timeframe. Be responsible for ensuring all QC sample, assay control and QC reagent storage areas are organised and that stocks of reagents are available and in date. Support the QC Manager with calibration and servicing activities, including liaising with relevant contractors to define CBF requirements and being responsible for organising pipette, balance and weight calibration for all CBF departments. Author and review documents, including SOPs and forms. Design, write and implement plans for the validation of equipment, software and assay techniques Carry out general laboratory housekeeping, ensuring tidiness, cleanliness and safe operation. Carry out QC sampling of new batches of chemicals and materials. Supervise the CBF environmental monitoring program. Provide cover for the QC Manager in their absence. Champion continual improvement for the QC department. Undertake any other duties as required that are commensurate with the grade and responsibilities of this post. 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. 1 • 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. Communication • • • • Advise Operations Manager of QC availability to enable the manufacturing schedule to be planned. Update the QA Manager and QC Manager regularly with quality related issues. Maintain confidentiality regarding data when interacting with external clients. Liaise with CBF suppliers and contractors. Education and training • • • Learn new laboratory techniques using 'on-the-job' training provided by experienced colleagues or staff working for the Sponsor. Continuously broaden, deepen and consolidate technical knowledge and skills. Attend appropriate seminars, training opportunities and meetings in the Jenner Institute and University. All employees will have to ensure that their work in the laboratory is conducted safely at all times and, in particular, that work is undertaken following the appropriate health and safety policies and procedures for the particular area, without compromise to their own safety or that of others who may be affected. Selection criteria Essential • • • • • • • • • • A Bachelor of Sciences degree in biology/biochemistry with laboratory experience. A high standard of literacy and numeracy and excellent verbal and written communication skills. Ability to design and implement validation experiments. High level practical skills and theoretical knowledge of standard molecular biology techniques and cell culture. Ability to follow verbal and written protocols and instructions. Ability to communicate and develop effective working relationships with a wide range of staff at all levels, internally and externally. Able to prioritise individual tasks to give a structured and organised approach. Good record-keeping skills and attention to detail. Computer literacy. Conscientious, well-organised and motivated and the ability to work independently and work as part of a cross functional team. Desirable • • Knowledge and understanding of Good Manufacturing Practice (GMP) and previous Quality Control experience in a formal quality management system. Ability to occasionally work outside standard working hours, as required, depending on business needs and willingness to be part of the on-call system out-of-hours. 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: • 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/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 4 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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We are seeking to appoint a Senior Quality Control Scientist to join our team at The Clinical BioManufacturing Facility (CBF). The 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. You will be based within the Quality Control department, under the supervision of the QC Manager, and responsible for the hands-on day-to-day running of the QC Laboratory, together with other Quality Control staff. You will be responsible for carrying out all work according to the regulatory guidelines of 'Good Manufacturing Practice' as defined in current version of the MHRA `Rules and Guidance for Pharmaceutical Manufacturers and Distributors', also known as the Orange Guide. You will be tasked with supervising the work of junior staff of the QC Department and training other CBF members in relevant SOP as required. You will be a point of contact for receipt, logging and scheduling of In-Process samples testing and will co-ordinate the stability study and clinical re-test schedule to ensure all testing is completed within the specified timeframe. You will also be responsible for carrying out general laboratory housekeeping, ensuring tidiness, cleanliness and safe operation as well as, carrying out QC sampling of new batches of chemicals and materials. It is essential that you hold a Bachelor of Sciences degree in biology/biochemistry with laboratory experience. You will have a high-level of practical skills and theoretical knowledge of standard molecular biology techniques and cell culture, as well as the ability to design and implement validation experiments. You will be conscientious, well-organised and motivated with the ability to work independently and work as part of a cross functional team and have the ability to communicate and develop effective working relationships with a wide range of staff at all levels, internally and externally. 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 Monday 8 April 2024 will be considered. Please quote 170224 on all correspondence.
Standard Grade 6: £32,332 - £38,205 with a discretionary range to £41,732 per annum
Wellcome Trust Centre Clinical Vaccinology and Tropical Medicine
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