Client Dedicated

il y a 2 semaines

IvrysurSeine, France Thermo Fisher Scientific Temps plein

Client Dedicated - Sr Scientist - Bioanalytics

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits

In this position you will work within our Client Dedicated team as a Senior Scientist Bioanalytics and be development and validation of pre-clinical and clinical bioanalytical assays. You will supervise the conduct of the bioanalytical work at CROs and review and write of bioanalytical sections in regulatory documents.

**Responsibilities**:

- Development and qualification/validation of bioanalytical assays (PK, PD, biomarkers and immunogenicity assays)
- Troubleshoot methods and implements state-of-the art methodologies
- Set up bioanalytical strategies for PK, PD and immunogenicity assessment during preclinical and clinical development
- Supervise, plan and coordinate assay transfer to bioanalytical CROs and monitor the development, qualification/validation and sample analysis activities at the CROs.
- Write study proposals and reports
- Review development and validation reports and quality documents
- Review sample analysis plans and reports for (pre-) clinical studies
- Partner with clinical development teams/project teams to align bioanalytical needs and responsible for execution of bioanalytical package during clinical trials or preclinical activities
- Write bioanalytical methodologies and results in regulatory documents
- Study relevant literature, be aware of scientific and bioanalytical development
- Write scientific publications in peer reviewed journals

**Requirements**:

- PhD degree and significant experience in industry in the field of bioanalytical sciences
- Solid background in development, qualification/validation and implementation of bioanalytical methods
- Proficient in study monitoring and management of CROs
- Extensive know-how of bioanalytical methods in the field of biologicals and antibody-derivedd therapeutics- Extensive knowledge in drug development spanning from pre-clinical to clinical Phase III studies- Strong emphasis on quality
- Knowledge of bioanalytical regulations in the pre-clinical and clinical setting - Excellent organizational and communication skills

**Our 4i Values**:
Integrity - Innovation - Intensity - Involvement

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