Scientific Programme Managers

**General Information**:
**Vacancy number**
- 1038/2025

**Recruitment type**
- External recruitment (international)

**Type of contract**
- Fixed-term appointment

**Posted date**
- 25-Jul-2025

**Deadline to apply**
- 01-Sep-2025

**Duty station**
- Strasbourg

**Grade**
- A1/A2

**Entity**
- European Directorate for the Quality of Medicines and HealthCare

**Description & Requirements**:
**Your Team**

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).

**Your Role**

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;

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.

**Requirements to apply**

You must:

- have at least 3 years’ recent, proven practical experience in a laboratory setting, including experience in elaborating and conducting experimental studies or in analytical procedure development in one or more relevant fields (e.g. vaccines, blood products, biotech products, gene therapy products); this experience may have been acquired in the pharmaceutical industry, an official medicines control laboratory, at university (e.g. during PhD studies) or in a similar institution;
- have very good knowledge of English;
- have a basic knowledge of French or the ability to learn it on the job.

You must also:

- be a citizen of one of the member states of the Council of Europe and fulfil the conditions for appointment to the civil service of that state;
- have discharged any obligation concerning national service (military, civil or comparable);
- not be the parent, child, stepchild or grandchild of a serving staff member of the Council of Europe;
- be under the age of 65 years.

**Key competencies**
- 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 analyti