Client Dedicated - Ivry-sur-Seine, France - Thermo Fisher Scientific

Thermo Fisher Scientific

Entreprise vérifiée

Ivry-sur-Seine, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

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 stateofthe 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 knowhow of bioanalytical methods in the field of biologicals and antibodyderivedd therapeutics
Extensive knowledge in drug development spanning from preclinical to clinical Phase III studies
Strong emphasis on quality
Knowledge of bioanalytical regulations in the preclinical and clinical setting
Excellent organizational and communication skills

Our 4i Values:

Integrity - Innovation - Intensity - Involvement