Damien Chevaillier

Scientific and technical missions:

* Development, validation of physicochemical analytical methods for active ingredients and their dosage forms (oral solution, prolonged-release film-coated tablets, solutions for injection).
* Participation in the establishment of the specifications and related monographs intended for the quality control of the clinical batches and the first industrial batches (in collaboration with the industrial affairs).
* Editorial contribution to CMC section of an e-CTD.
* Elaboration and analytical follow-up of exploratory or regulatory stability studies.
* Analytical support to pharmaceutical and chemical development teams.
* Organization and supervision analytical transfers to industrial development and quality control laboratories of the future production sites.

“Analytical Sciences” team representative responsibility within an international project group for one of the molecules under development in the team.

Team Management:
management of technicians (4 people min.), construction of planning according to projects, compliance with the cGMP and safety rules for the laboratory.

Scientific and technical missions:

* Development and validation of the physicochemical analytical methods for active ingredients and their dosage forms (soft gelatine capsules and immediate release film-coated tablets).
* Participation in the establishment of the specifications and related monographs intended for the quality control of the clinical batches. Editorial contribution to sections CMC of clinical studies dossiers (IND, IMPD).
* Elaboration and analytical follow-up of exploratory or regulatory stability studies (Phases I to III).
* Analytical support to pharmaceutical development team. Contribution to the management process of genotoxic impurities potentially present in the studied active ingredients.

“Analytical Sciences” team representative responsibility within an international project group for one of the molecules under development in the team.

Team co-management:
management of technicians (4 to 6 people), construction of planning, compliance with the cGMP and safety rules for the laboratory.

In charge of the validations, investigations and analytical support, according to the needs for the pilot plant, the production and according cGMP's requirements, mainly by the application of LC, GC and spectrometric methods.

In charge of the follow-up of stability studies.

Management of 3 technicians.

Industrial placement at the pharmaceutical development laboratory.
Elaboration and application of study protocols to solve a quality issue for a commercial product. Use of capillary zone electrophoresis. Validation of analytical methods using enoval®. Work under GMP environment.

1 year of placement in the analytical development laboratory. Development and validation of analytical methods according to ICH guidelines ; in particular in HPLC-DAD and GC-FID. Elaboration of study protocols. Work under cGMP/BPF environment.