Manager Sénior Sourcing et Développement des Principes Actifs H/F - 33

Pour renforcer au sein de la R&D notre département de scouting, sourcing et développement de nouveaux principes actifs pharmaceutiques, nous recherchons un(e) manager des activités de sourcing et de développement des principes actifs pour un poste en CDI.

Au sein de l'équipe du développement pharmaceutique des nouveaux médicaments vétérinaires et en relation étroite avec le groupe innovation, vous serez une interface entre innovation et développement, vous piloterez le sourcing et les appels d'offres pour les nouveaux fournisseurs ou CDMOs ainsi que les développements externes des nouveaux principes actifs, dans le cadre des nouveaux projets. Vous serez aussi force de proposition en matière d'innovation et de nouvelles opportunités.

Missions Principales :
Innovation :
Participer aux évaluations des opportunités externes (due diligences).
Participer avec le service innovation aux optimisations des leads retenus en collaboration avec des CROs et en s'appuyant sur des expertises internes & externes.

Sélection :
Définir les besoins liés au projet. Participer au process d'évaluation et de sélection des fabricants ou des CDMOs. Etablir un rationnel de choix.

Développements externes des principes actifs :
Gérer les contrats des CDMOs/fournisseurs en liaison avec le département des achats et le département juridique.
Piloter les activités de développements externes des principes actifs (synthèse, analytique, production, validations, données scientifiques...) en assurant le niveau requis en matière de BPF et d'HSE et dans l'optique de futurs lancements commerciaux.
Fournir aux affaires règlementaires les données CMC nécessaires à la constitution des dossiers d'enregistrement et aux réponses aux questions des agences du médicament, en vue d'obtenir des autorisations de mise sur le marché.

Le poste sera en interfaces principalement avec les services innovation, formulation, développement analytique et microbiologique, les achats, les services réglementaires, l'AQ, le service brevet, le service juridique et les ressources externes (universités, start-up, sociétés pharma et agro, CRO, CDMO, experts ...).Manager sourcing and development activities for active ingredients

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our Together, Beyond Animal Health vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our Diversity, Equity and Inclusion policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your
missions :

To strengthen our R&D department responsible for scouting, sourcing, and developing new active pharmaceutical ingredients, we are looking for a manager to oversee sourcing and development activities for a permanent position.

As part of the pharmaceutical development team for new veterinary drugs and working closely with the innovation group, you will act as an interface between innovation and development, overseeing sourcing and calls for tenders for new suppliers or CDMOs, as well as external developments of new active ingredients within the framework of new projects. You will also be a source of proposals for innovation and new opportunities.

Main responsibilities:
- Innovation:
Participate in the evaluation of external opportunities (due diligence).
Work with the innovation department to optimize selected leads in collaboration with CROs and drawing on internal and external expertise.

- Selection:
Define project requirements. Participate in the evaluation and selection process for manufacturers or CDMOs. Establish a rationale for selection.

- External development of active ingredients:
Manage CDMO/supplier contracts in conjunction with the purchasing and legal departments.
Oversee external development activities for active ingredients (synthesis, analysis, production, validation, scientific data, etc.) while ensuring compliance with GMP and HSE requirements and with a view to future commercial launches.
Provide regulatory affairs with the CMC data necessary for compiling registration dossiers and responding to questions from drug agencies, with a view to obtaining marketing authorizations.

The position will mainly interface with the innovation, formulation, analytical and microbiological development, purchasing, regulatory, QA, patent, legal departments, and external resources (universities, start-ups, pharmaceutical and agricultural companies, CROs, CDMOs, experts, etc.).

Your
profile :

Minimum 5 years of higher education (chemical engineer, master's or doctorate in chemistry, pharmacist, etc.) with proven experience in this type of position.

A good knowledge of pharmaceutical development, an interest in product innovation, and an active network of external resources are essential for success in this position.

You are curious and proactive, and know how to work in a multidisciplinary team.

In terms of interpersonal skills, good direct and cross-functional management skills are essential for success in your assignments.