Head of Analytical Development, R&D

Located 1 hour from Rennes and Le Mans and 1.5 hours from Paris by train, the Ceva Laval Campus is our centre of excellence for companion animals (dogs and cats). Within the Research and Development department of this Campus, we are looking for an Analytical Manager to strengthen the analytical development team. As part of the pharmaceutical R D team, you will contribute to the development of future pharmaceutical products for the Ceva group. Your responsibilities will include: - Ensuring the analytical development of the products entrusted to you, in accordance with development plans and specifications. This involves developing methods for dosing and characterisation using HPLC, UHPLC, GC, KF, IR, UV, dissolution, etc., either in-house or through subcontractors. - Working closely with the formulation department (to develop the formula) and the various project team members: Project Manager, Industrial Development, EU and US Regulatory Affairs Manager, etc. - Managing a team of analytical technicians (planning their activities, providing technical support, etc.). - Pre-validate analytical methods and draft pre-validation protocols and reports in accordance with international guidelines (ICH, VICH, FDA, EMA, etc.). - Manage the transfer of analytical methods to and from internal QC laboratories or international subcontractors (drafting protocols and reports, choosing acceptance criteria, etc.). - Coordinate activities related to cGMP compliance in the analytical laboratory (drafting procedures, monitoring CAPA, deviations, etc.). - Draft the analytical documentation required for new marketing authorisation applications and monitor technological and documentary developments concerning pharmacopoeias.