CMC Expert M/F (CDI)

Qui sommes-nous ? Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain! Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du "We Care Movement". Votre mission We are recruiting a CMC Expert on a permanent contract for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Medical Care's R&D Department . You will be responsible for the development and manufacturing of new drug candidates. This includes selection and optimization of small molecule synthesis routes, manufacturing support, scale-up process and technology transfer of the active, characterization of RSM and impurities, validation of development activities for validation, definition of specifications and validation of processes. Your role within a pioneering company in full expansion: More specifically, you will: - Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a CMC expert. Carry out CMC quality reviews (module 3) of product and project dossiers as an in-house expert, and provide chemical expertise as part of Due Diligences. - You sign QOS and variations requiring signed CMC expertise (1.4.1). - Analyze and appraise product issues relating to analytics, and assess the work required to resolve them. - Provide chemical expertise (analytical and CMC) for all requests, as well as technological and CMC watch. You are responsible for the CMC Work Package for new projects, in cross-functional collaboration with clinical, non-clinical, research, regulatory, quality and other departments. - You will be responsible for monitoring work in line with this strategy, in terms of quality/cost/timeframe, with internal departments and subcontractors, and will provide expert support and scientific guidance to CMC subcontractors. - Represent Pierre Fabre's CMC expertise to the authorities in case of questions. You draft and/or check the CMC parts of INDs/IMPDs/NDAs/MAAs, including questions and answers to the authorities. - Define and manage the chemistry budget for all development phases - Support as chemistry expert internal life cycle management programs and regulatory changes for assets and raw materials (i.e. nitrosamines report assessment, ethylene glycol and diethylene glycol assessment, regulatory changes...). This position is compatible with teleworking up to 2 days a week according company rules. We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation... Qui êtes-vous ? Your skills at the service of innovative projects: Chemical engineer or PhD in chemistry Minimum 10 years' experience in CMC expertise acquired through several clinical studies (phase 1 to phase 3), ideally up to registration. Fluent English essential Extensive experience in Good Manufacturing Practices (cGMP) You have managed a CDMO Experience of technical leadership in chemistry and project management associated with development programs is required. La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre. Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir l’égalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction d’origine, de sexe, d’âge, de situation de handicap, d’orientation sexuelle, d’identité de genre, de croyances ou de toute autre caractéristique protégée par la loi.