Job description and selection criteria

Transcription

1 Old Road Campus Research Building Job description and selection criteria Job title Division Department Location Grade and salary Hours Contract type Reporting to Regulatory Compliance Expert: Drug/Device Combination Products Medical Sciences Nuffield Department of Medicine (NDM) Clinical BioManufacturing Facility, Oxford University, Churchill Drive, Headington. Oxford. OX3 7JT Grade 8, 39,324 46,924 per annum Full time Fixed-term 3 years in the first instance Senior Qualified Person/Project Lead Vacancy reference Additional information This role is the equivalent of a QP for Devices. Person must have first-hand experience with Class III Medical Devices Security screening will apply for this post. The role Working with academics but embedded in an existing MHRA licenced facility currently manufacturing novel first in man investigational medicinal products, this new role is to be the devices expert. Responsible for ensuring that all regulatory compliance and manufacturing requirements for class III (combination) devices can be met, influencing early in the developmental lifecycle with the academics, through to manufacture and release for use in first in man clinical trials. You will be the person responsible for regulatory compliance activities that possess expert knowledge in the field of medical devices as defined under Article 13 of the medical device directive. He/she may be a named responsible person on MHRA license MAI (IMP) held by the Clinical BioManufacturing Facility (CBF) in accordance with the requirements of European Community Statutory Directive 2001/83/EEC.

2 Scope of the role Working closely with the CBF Qualified Persons who are responsible for the medicinal products, this role the Regulatory Compliance Expert: Drug/Device Combination Investigational Products (RCE) includes total responsibility for all regulatory aspects of the development cycle, manufacture and clinical trial use of the device parts of experimental combination devices being developed in the OXCD 3 centre. Due to the fast changing nature of regulations in this field this person will be the expert point of contact for academics and other staff requiring advice in this field. The role of Regulatory Compliance supports all of the CBF activity, and provides expert advice on research programmes for all OXCD 3 and Jenner Institute investigators and supporting collaborations. At least two OXCD 3 projects are expected to be manufactured in the CBF during 2018 and this role is to primarily ensure smooth and effective transition from a regulatory perspective. The Oxford Centre for Drug Delivery Devices (OxCD 3 ) The Oxford Centre for Drug Delivery Devices (OxCD 3 ) is a new 10m multi-disciplinary research centre supported by a 5-year EPSRC Programme Grant in partnership with 10 industrial partners from across the medical device and pharmaceutical sectors. The Centre will develop engineering approaches, from inception to manufacture, for device-based delivery of novel classes of anti-cancer therapeutics including sirna, radiopharmaceuticals, viruses and antibodies. A key focus of OxCD 3 is the exploitation of physical mechanisms triggered by ultrasound, magnetic fields or shock waves, involving a combination of stimulusresponsive nanoparticles and medical devices already in clinical use to improve the delivery and penetration of drugs into tumours. Led by Prof. Constantin Coussios, the Centre is a dynamic partnership between Oxford University s Institute of Biomedical Engineering, the Department of Oncology, the MRC Weatherall Institute of Molecular Medicine, the Nuffield Department of Surgical Science and the Clinical Biomanufacturing Facility. For further information, please see The RCE may be called upon to support or provide expert advice to other University of Oxford academics (outside the above scope of role) however this is not the core part of the role and will be undertaken subject to availability of time and within the persons own level of expertise. Responsibilities The RCE will be responsible for carrying out legal duties as a Person Responsible for Regulatory Compliance in accordance with evolving legislation in this area (the translational manufacture of and clinical trials with combination devices). At the current time this includes Medical Device Directive 93/42/EEC, the Active Implantable Medical Device Directive 90/385/EEC, Directive 2001/83/EC, ensuring compliance with the requirements of Annex13 of the EU Guidance on GMP for clinical IMPs and where relevant Annex 16 Certification by a Qualified Person & Batch Release. The responsibilities of this role being the expert on all evolving legislation throughout these areas and advising other senior CBF staff members of upcoming changes Reporting at the CBF to the Senior Qualified Person your duties will be varied, however, the key duties and responsibilities are as follows:

3 Duties Person Responsible for Regulatory Compliance of Medical Devices & Drug/Device Combination Products manufactured at the CBF. (The equivalent of a QP in the medicines arena). Leading on submissions and queries in the Devices area to the Medicines and Healthcare products Regulatory Agency (MHRA). Advising OXCD 3 and the Jenner Institute partners on the interpretation and application of current relevant legislation and guidance that has an impact on Devices manufacturing as related to clinical trials activity. Advise OXCD 3 researches on preferred routes for API encapsulation and modification for regulatory compliance, manufacturability and systemic administration. Ensure suitable policies and procedures for the manufacture of devices are captured and written. Gap analyse and undertake risk assessments as required for all device related areas (processes, materials, manufacture, clinical use) at a level suitable to present to the regulator. To assist in ensuring that the Quality Systems are robust, effectively implemented and utilised in order to support competent decision making for Device release, including: review, approval and authorisation as applicable (policies, procedures, specifications, standard operating procedures, validation and other documents). Ensure the academic preclinical research in OXCD 3 projects intending manufacture at the CBF are utilising methodology and materials that are transferrable and compatible with the expectations of GMP thus ensuring efficient technical transfer to a manufacturing environment. Understand technology transfer and give regulatory support & guidance to staff (academic and clinical researchers as well as CBF staff) enabling the introduction & manufacture of novel manufacturing processes and products to the CBF that meet the requirements of EU GMP. Implementation of the requirements of evolving Clinical Device legislation & support the CBF QMS. Assisting senior staff QA and QPs with implementation of EU Commission Directive 394/2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC2005. May be responsible for investigation and reporting of suspect / defective medicinal products and medical devices. This role will be central and pivotal to the operation and the quality standards of the Clinical BioManufacturing Facility. This is an unusual and highly varied role due to the nature and scope of the translational products being manufactured at the Clinical BioManufacturing Facility, often for diseases where the correlate of protection is unknown.

4 Communication To provide expert guidance and advice to colleagues, sponsors and clinicians on regulatory issues in the medical device area & general regulatory issues. To assist with the preparation of documentation to support Regulatory Submissions Including: o Clinical Trials Applications (IMPD) and related documents. o Provide expert technical justifications in response to regulators questions (UK and European). o Prepare support for specialist regulatory advice submissions. To verbally communicate with the regulatory bodies in conjunction with above as required. To communicate with sponsors and international collaborators maintaining sponsor confidentiality when interacting with other researchers. To present the work of the CBF at internal and external scientific and business meetings. To network with other local QPs/Regulatory Compliance Experts for Devices. Education and Training A science degree, preferably a second degree and a strong track record in quality assurance gained in the pharmaceutical, devices or healthcare industries preferably manufacturing sterile products. Previous professional experience in regulatory affairs or in quality management systems relating to medical devices. Meet the requirements of continuing professional development in the regulatory arena. To attend appropriate MHRA seminars, scientific and regulatory compliance training opportunities and meetings within the University and externally. Support and train CBF staff and sponsors with all aspects of Medical Device regulations and requirements. To participate in the specific GMP education and training of other staff throughout the University as necessary and appropriate. Other General Responsibilities To perform and review change controls and risk assessments of working arrangements and to risk assess in advance any proposed changes or new procedures. To undertake such other duties as may be required from time to time that are commensurate with the grade and responsibilities of this post. To conduct themselves with due regard to the University Equal Opportunities and Data Protection policies. You will occasionally be required to work outside normal working hours. Person Specification: You must have experience with class III Medical Devices and show independent responsibility and discretion.

5 A thorough understanding of formulation will be key to this position especially with regards to formulation of micro & nanoparticles (such as liposomes or viruses) for IV administration. In order to meet these requirements you must have a science degree, preferably a second degree and a strong track record in quality assurance gained in the pharmaceutical, devices or healthcare industries preferably manufacturing sterile products. Extensive knowledge, interpretation and application of quality management within a GXP environment are essential particularly in early phase clinical trials. You must be able to work as a team member but imperative at the same time to be able to extend your authority and ensure that all regulatory requirements are met and are able to influence the development of policy decisions and strategic plans. You should be an effective communicator with a broad spectrum of coworkers (from professors, hands on researchers and GMP staff working in regulated environments) with good presentational skills and experience of training. You should meet the essential criteria below and match most of the desirable criteria: Hazard-specific / Safety-critical duties This job includes the following hazard-specific or safety-critical duties which will require successful pre-employment health screening through our Occupational Health Department before the successful candidate will be allowed to start work: Safety-critical work Additional security pre-employment checks This job includes the following duties which will require additional security pre-employment checks: A satisfactory Disclosure Scotland check due to working with sensitive information. Selection criteria Essential selection criteria A science degree (or equivalent) or near completion. Prior experience with Class III Medical Devices & drug/device combination products. Previous professional experience in regulatory affairs or in quality management systems relating to medical devices. Demonstrated excellent interpersonal skills with the ability to work with and influence senior (external to manufacturing) staff to ensure robust and reliable systems in place. Previous experience of Sterilisation Validation as applied to medical devices. Experience with GXP manufacture of nanoparticles and microparticles, ideally in combination with API. Ability to interpret existing and upcoming directives in the drug and device formulation. Able to advise on suitability of raw materials and chemicals. Previous experience of writing high level risk assessments (at a level suitable to share with regulators).

6 Desirable selection criteria A postgraduate degree (MSc, PhD or similar) in a related discipline, such as biochemistry or pharmaceutical sciences. Prior professional experience in regulatory affairs or in quality management systems relating to medical devices. Prior experience of manufacturing vaccines / Advanced Therapy Medicinal Products (ATMPs) / Adjuvants to meet the GMP requirements. Experience hosting regulatory inspections. Ability to learn new techniques and how they may be used to develop novel IMP combination device release tests. A proven ability to work independently, under pressure without compromising on deliverables. Self-motivated with solid planning and organisational capabilities. Critical attention to detail. About the University of Oxford Welcome to the University of Oxford. We aim to lead the world in research and education for the benefit of society both in the UK and globally. Oxford s researchers engage with academic, commercial and cultural partners across the world to stimulate high-quality research and enable innovation through a broad range of social, policy and economic impacts. We believe our strengths lie both in empowering individuals and teams to address fundamental questions of global significance, and in providing all of our staff with a welcoming and inclusive workplace that supports everyone to develop and do their best work. Recognising that diversity is a great strength, and vital for innovation and creativity, we aspire to build a truly diverse community which values and respects every individual s unique contribution. While we have long traditions of scholarship, we are also forward-looking, creative and cutting-edge. Oxford is one of Europe's most entrepreneurial universities. Income from external research contracts in 2014/15 exceeded 522.9m and ranked first in the UK for university spin-outs, with more than 130 spin-off companies created to date. We are also recognised as leaders in support for social enterprise. Join us and you will find a unique, democratic and international community, a great range of staff benefits and access to a vibrant array of cultural activities in the beautiful city of Oxford. For more information please visit Medical Sciences The Medical Sciences Division is an internationally recognized centre of excellence for biomedical and clinical research and teaching.

7 We are the largest academic division in the University of Oxford World-leading programmes, housed in state-of-the-art facilities, cover the full range of scientific endeavour from the molecule to the population. With our NHS partners we also foster the highest possible standards in patient care. For more information please visit: Nuffield Department of Clinical Medicine (NDM) The Nuffield Department of Clinical Medicine (NDM) is one of the largest departments of the University of Oxford and is part of the Medical Sciences Division, with responsibility for a significant part of the teaching of clinical students within the Medical School. The Department also has a substantial research programme which requires high quality administrative management. NDM has significant financial turnover and complexity, resulting from its diverse research portfolio, its geographical spread and its close links with NHS funding and strategic teams involved in the development and delivery of increasingly integrated clinical research platforms....fostering your career in science For more information please visit: The University of Oxford is a member of the Athena SWAN Charter and holds an institutional Bronze Athena SWAN award. The Nuffield Department of Medicine holds a Silver Athena SWAN award to recognise advancement of gender equality: representation, progression and success for all. For more information please visit: Clinical BioManufacturing Facility The Clinical BioManufacturing Facility is the University of Oxford s GMP (Good Manufacturing Practice) manufacturing facility, where the basic research into vaccines and potential advanced therapies can be translated into an Investigational Medicinal Product (IMP) used in first in man clinical trials. The CBF has 20 years experience producing biological IMPs according to GMP for early phase clinical trials. It has a Manufacturer s Authorisation for Investigational Medicinal Products (MA IMPs) from the Medicines and Healthcare Products Regulatory Agency (MHRA) and is currently manufacturing adenoviral vectors for use as novel vaccines and cancer therapies For more information please visit: How to apply Before submitting an application, you may find it helpful to read the Tips on applying for a job at the University of Oxford document, at

8 If you would like to apply, click on the Apply Now button on the Job Details page and follow the on-screen instructions to register as a new user or log-in if you have applied previously. Please provide details of three referees and indicate whether we can contact them now. You will also be asked to upload a CV and a supporting statement. The supporting statement should explain how you meet 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. All applications must be received by midday 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 departments. If you are a priority candidate, please ensure that you attach your redeployment letter to your application (or it to the contact address on the advert if the application form used for the vacancy does not allow attachments) Should you experience any difficulties using the online application system, please recruitment.support@admin.ox.ac.uk. Further help and support is available from To return to the online application at any stage, please go to: Please note that you will be notified of the progress of your application by automatic s from our e-recruitment system. Please check your spam/junk mail regularly to ensure that you receive all s. Important information for candidates Pre-employment screening Please note that the appointment of the successful candidate will be subject to standard preemployment screening, as applicable to the post. This will include right-to-work, proof of identity and references. We advise all applicants to read the candidate notes on the University s pre-employment screening procedures, found at: The University s policy on retirement The University operates an employer justified retirement age for all academic and academicrelated posts (grade 6 and above), for which the retirement date is the 30 September

9 immediately preceding the 68th birthday. The justification for this is explained at: For existing employees any employment beyond the retirement age is subject to approval through the procedures: There is no normal or fixed age at which support staff in posts at grades 1 5 have to retire. Support staff may retire once they reach the minimum pension age stipulated in the Rules of the pension scheme to which they belong. 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.

10 Benefits of working at the University Training and Development A range of training and development opportunities are available at the University. Further details can be found at For research staff only: Support for Research Staff There is a particularly wide range of support for career development for research staff. Please visit: to find out more. Pensions The University offers generous occupational pension schemes for eligible staff members. Further details can be found at Information for international staff (or those relocating from another part of the UK) A wealth of information is available on the University's International Staff website for staff who are relocating to Oxford from abroad, at The University of Oxford Newcomers' Club The Newcomers' Club is aimed at helping partners of newly-arrived visiting scholars, graduate students and academic members of the University to settle in and to meet people in Oxford. Transport schemes The University offers a range of travel schemes and public transport travel discounts to staff. Full details are available at University Club and University Sports Facilities The University Club provides social, sporting and hospitality facilities. It incorporates a Club bar, a cafe and sporting facilities, including a gym. See for all further details. University staff can use the University Sports Centre at discounted rates, and have the chance to join sports clubs. Please visit Childcare and Childcare Vouchers The University offers quality childcare provision services at affordable prices to its employees. For full details about the services offered, please visit NB: Due to the high demand for the University s nursery places there is a long waiting list. The University also offers nursery fee payment schemes to eligible staff as an opportunity to save tax and national insurance on childcare costs. Please visit Disabled staff The University is committed to supporting members of staff with a disability or long-term health condition and has a dedicated Staff Disability Advisor. Please visit for further details. BUPA - Eduhealth Bupa Eduhealth Essentials private medical insurance offers special rates for University of Oxford staff and their families All other benefits For other benefits, such as free entry to colleges, the Botanic Gardens and staff discounts offered by third party companies, please see