Senior Specialist

Company Description
**Join our Team**

***With more than 50,000 employees in 50 countries, Eurofins provides analysis services to the pharmaceutical, food and environmental industries. At the forefront of the latest developments in biotechnology, in very strong growth and a leader in its field of activity, Eurofins is a dynamic and ambitious company with the vision of becoming the world leader in the bio-analysis market. Joining Eurofins means starting an experience rich in challenges for a promising career.

PSS is our award winning service model where we provide and manage scientific services directly within our clients’ facilities, mainly within the pharmaceutical sector. It is a global service offering and we have been managing services through this model since 2002.

We are currently looking for an experienced professional to join our French team as Senior Specialist (M/F/d) API Analytical Transfer & Restructuring within our Professional Scientific Services Division (PSS). This position should be affiliated in the French department of Eure (27) and will require up to 10% international travel.

**Senior Specialist (M/F/d) API Analytical Transfer & Restructuring**

**Job Description**:
Your mission will be to lead and execute analytical transfer activities for both, R&D to site as well as for site to site for active pharmaceutical ingredients (APIs).

**Key Responsibilities**:

- Supports PATS API analytical transfers for active pharmaceutical ingredients (APIs)
- Focus on analytical method’s regulatory and quality compliance against current guidelines from pharmaceutical GMP authorities, readiness for submission by a detailed document analysis
- Focus on applicability of methods in routine Quality Control (QC) environment
- Identifying method improvement opportunities in terms of method modernization and/or robustness
- Supports preparation of transfer strategy in terms of submission readiness
- Supports troubleshooting at the supplier in case of analytical investigations and critical method development needs
- Collaborates with Regulatory Affairs (RA), API technology team, external Quality, external suppliers and division site responsible teams in transfer activities
- Supports several API analytical transfer activities simultaneously.

**Qualifications**:

- Master, Bachelor, Engineer degree and long year experience in a Pharmaceutical/Chemical/Analytical Science required
- At least 8 years’ experience in the research and development, manufacturing and testing of active pharmaceutical ingredients (APIs) or drug products required
- Experience in analytical transfer activities and broad understanding of analytical platforms like pharmaceutical analyses (wet chemistry, chromatography and physicochemical testing) is an advantage
- Experience in submission process and review of dossiers is an advantage
- Solid experience working in international project teams
- Ability to work independently and make decisions within guidelines and policies that impact own priorities to meet deadlines
- Proficient in scientific/technical writing and current computer usage (Word, Excel, PowerPoint, MS Project etc.)

You want to enhance your skills in a dynamic company offering real career prospects, then join us