: Renewable fixed term contract
: Strasbourg (France)
The European Directorate for the Quality of Medicines & HealthCare (EDQM)
is a leading organisation whose mission is to contribute to the protection of public health by promoting access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific benchmark worldwide. These standards for medicines and their ingredients are compiled in the European Pharmacopoeia and are legally binding in 39 European member States (and the European Union) but are widely used in the human and animal health sectors across the globe. The EDQM also develops guidance and standards in the areas of blood transfusion, organ, tissue and cell transplantation and consumer health issues such as cosmetics and food contact materials.
Who Can Apply:
As a minimum, you must:
Demonstrate to us that you have the following competencies:
- Hold a higher education degree or qualification equivalent to a master’s degree (2nd cycle of the Bologna process framework of qualifications for the European Higher Education) in pharmacy, immunology, molecular biology, virology, a gene therapy-related field, cell therapy, medicine, biochemistry or bioengineering;
- Have a minimum of 4 years of proven and recent relevant professional experience in a laboratory setting, including experience in elaborating and conducting experimental studies or analytical method development in one or more relevant fields (e.g. gene therapy products, biotechnology products, vaccines, blood-derived medicinal products);
- Have very good knowledge of one of the two Council of Europe’s official languages (English) and knowledge of the other (French) with the capacity to improve if necessary;
- Be a citizen of one of the 47 member States of the Council of Europe;
- Be under 65 years of age at the closing date of this vacancy notice.
- Professional and technical expertise in at least one of the following:
- planning and performance of laboratory studies in fields such as advanced therapy medicinal products, molecular
biology, biotechnology, vaccines, biotherapeutic products or blood derived medicinal products;
- analytical methods or analytical method validation for the control of biological products (for example, biotechnology
products, gene therapy products, vaccines or blood-derived medicinal products).
These would be an asset:
- Planning and work organisation
- Analysis and problem solving
- Concern for quality
- Results orientation
- Teamwork and co-operation
- Relationship building
- Professional and technical expertise:
- familiarity with regulations linked to standard-setting for medicinal products, particularly in the biological standardisation field, (e.g. biotechnology products, gene therapy products, vaccines or blood-derived medicinal products);
- evaluation of marketing authorisation applications for biologicals at national or European competent authority level;
- strong academic background and/or a further degree in a relevant domain covering topics such as gene therapy products, recombinant viral vectored vaccines or monoclonal antibodies;
- specific knowledge of gene therapy or vaccine viral vector testing or manufacturing approaches.
Main responsibilities of the Scientific Programme Manager:
What EDQM offers:
- Plan and co-ordinate activities and follow-up on actions for assigned Biological Standardisation projects, including liaising with the EDQM’s Department for Reference Standards and Logistics or external partners for the acquisition and production of biological reference preparations;
- Work with project leaders to establish protocols for the evaluation of candidate materials;
- Coordinate collaborative laboratory studies;
- Initiate the follow-up of studies (e.g. the monitoring of reference materials, reporting of results obtained with newly established standards);
- Coordinating scientific studies; carrying out background studies/research; investigating issues, gathering and analysing scientific data, preparing reports and actions; supporting the statistical evaluation of the study results with the project statistician;
- Drafting or co-ordinating the drafting of study reports for expert groups and steering committees and for publication in Pharmeuropa Bio & Scientific Notes and/or other scientific journals;
- Responding to stakeholders’ questions; drafting press releases or news items; representing the EDQM in meetings, conferences and seminars or during visits;
- Developing and maintaining contacts with other scientific staff within the EDQM and with counterparts in relevant industries and scientific and regulatory bodies active in the sector in order to remain abreast of and adopt changing practices, approaches and technology, etc. into working methods.
Applications and selection procedure:
- a good insight into the European regulatory framework from the EDQM perspective and the opportunity to work in a leading international organisation in the field of public health protection - the Ph. Eur. is Europe’s legal and scientific benchmark for pharmacopoeial standards, contributing to delivering high quality medicines in Europe and beyond;
- personal growth through a range of learning & development options to improve your competencies including technical and language training, a structured induction plan and coaching, and access to over 70 online courses;
- a real cultural melting pot as there are over 20 nationalities working at the EDQM which is situated in the European quarter of Strasbourg;
- 32 working days leave per year and flexible working hours between 7h-19h and more flexibility through teleworking following completion of your probationary period;
- an attractive income tax-free salary and benefits package, including health insurance and additional allowances such as family and expatriation allowances (as appropriate).
- Applications must be made in English or French. You can create and submit your online application. Please fill out the online application form providing all requested details. It usually takes a few hours to fill in an application form, so please take this information into consideration while applying.
- Only applicants who best meet the abovementioned criteria will be considered for the next stage, which will consist of assessments and an interview. Further information on the assessment process will be provided to the selected candidates in due course.
As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified candidates, irrespective of sex, gender, marital or parental status, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunities policy, the Council of Europe is aiming to achieve parity in the number of women and men employed at all levels in the Organisation. In the event
of equal merit, preference will therefore be given to the applicant belonging to the under-represented sex in the grade. During the different stages of the recruitment procedure, specific measures may be taken to ensure equal opportunities for candidates with disabilities.
If you meet the eligibility criteria and have the nationality of one of the 47 member states, please submit your application using the apply link