Scientific Programme Managers

The European Directorate for the Quality of Medicines & Healthcare (EDQM) is a leading organisation whose mission is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting acces to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific bookmark worldwide. the EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopeia, are legally binding in its 39 member states (and the European Union) and are also widely used across the globe in the human and animal health sectors. The EDQM also plays a crucial role in the areas of blood transfusion, organ, tissue and cell transplantation and in developing and setting consumer health standards, such as for cosmetics and food contact materials.

Two teams within the European Pharmacopoeia Department are looking for new colleagues: 

Biological Standardisation Programme (BSP) Section: the primary role of this team is to establish reference materials and standardise analytical procedures for the quality control of biologicals. The BSP also participates in the development and validation of alternative methods that support the replacement, reduction and refinement of animal use on laboratory testing (the 3Rs principles). 

Biologicals Division (Division B): the primary role of this team is to co-ordinate the drafting of European Pharmacopoeia texts in the field of biologicals and microbiology, working closely with a network of subject matter experts.

As a Scientific Programme Manager in the Biological Standardisation Programme (BSP) Section, your role will focus on:

• co-ordinating various scientific projects of the BSP and their follow-up studies (e.g. monitoring reference materials, reporting results obtained with new standards), including:
  • working with experts, external project leaders, manufacturers and other stakeholders, in accordance with Council of Europe/EDQM policies, procedures, instructions, priorities and deadlines, to define and organise studies, including collaborative testing, and carrying out study-related activities;  
  • playing an active role in the preparation and review of study protocols for BSP projects and in the analysis of study results; providing technical and scientific expertise and finding suitable solutions to challenges encountered; 
• co-ordinating the preparation of study reports; presenting study progress reports and final results to the relevant groups and at relevant scientific conferences/symposia; preparing study reports for publication in scientific journals; participating in the organisation of EDQM conferences and seminars where the subject is relevant to the corresponding field of activity.

As a Scientific Programme Manager in the Biologicals Division (Division B), your role will focus on:

• drafting European Pharmacopoeia (Ph. Eur.) texts (monographs and general chapters) for publication in Pharmeuropa (for public consultation) and subsequent adoption by the European Pharmacopoeia Commission, in close co-operation with experts in the field, on the basis of the scientific data and information available (such as batch data, validation protocols and reports);
• managing the groups of experts/working parties that elaborate and revise Ph. Eur. texts and are assigned to you, including:
  • planning and co-ordinating activities and following up actions, providing advice to the group chairs and experts as necessary; 
  • proposing the addition of new items to the work programme, evaluating requests for revision of published texts. 
• potentially playing an active role in the drafting of validation or verification protocols for methods of analysis to be included in Ph. Eur. texts and in engaging with stakeholders to promote the understanding of the Ph. Eur.

• Operational - Planning and work organisation
• Operational - Analysis and problem solving
• Operational - Concern for quality
• Interpersonal - Communication

• Professional and technical expertise:

• experience in development and validation of analytical procedures applied in the quality control of biologicals (in an official medicines control laboratory, an analogous organisation or in the pharmaceutical industry).

• Operational - Learning and development
• Interpersonal - Service orientation

• Professional and technical expertise:

• experience of project management;
• familiarity with the development and use of reference materials;
• knowledge of regulatory frameworks for the quality control of biologicals.

  
  

This job vacancy is for an international external recruitment. You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage What we offer. 

For more information on how we recruit, you can consult the page Our recruitment process. This recruitment is carried out in accordance with Article 490 of the Council of Europe Staff Rules. The deadline for applications is indicated in the General information section of this vacancy notice (see above) and is fixed at 23:59:59 (CET/CEST). When applying, make sure your motivation shows how your competencies make your profile the best for the role.

As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified people, irrespective of sex, gender, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunity policy, the Council of Europe is aiming to achieve gender parity in staff employed in each category and grade. At the time of appointment, preference between suitable people shall be given to the person of the gender which is under-represented in the relevant grades within the category to which the vacancy belongs.

Applicants with specific needs are encouraged to request reasonable accommodations at any stage during the recruitment process. Please contact us at [email protected], we will ensure that your request is handled.

The information published on the CoE’s careers website regarding working conditions is correct at the time of publication of the vacancy notice. Any changes to these conditions during the recruitment process will be updated on our Portal and will apply at the time of the job offer. Our career's website is not intended to be exhaustive and may not address all questions you would have. Should you have remaining questions, please contact us at [email protected].