Formulation Expert M/F - CDI

Job description

Who we are ? We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement". Your mission We are recruiting a solid and sterile Formulation 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 solid and sterile formulation, manufacturing support, scale-up process and technology transfer of the drug product, characterization of the drug product process steps, development of the activities for validation, definition of specifications and process validation. 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 formulation expert. Carry out CMC quality reviews (module 3) of product and project dossiers as an in-house expert, and provide drug product expertise as part of Due Diligences. You review and validate QOS and variations requiring formulation expertise. Analyze and appraise product issues relating to formulation & manufacturing, and assess the work required to resolve them. Provide formulation and manufacturing expertise 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 formulation & manufacturing 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 formulation & drug product manufacturing budget for all development phases Support as formulation expert internal life cycle management programs and regulatory changes for assets and raw materials (i.e. manufacturing equipment changes, new sourcing of raw material, manufacturing process optimization…). This position is compatible with teleworking up to 2 days a week according to 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, very attractive CE... ------------------------------ Nous recrutons en CDI pour notre site de Toulouse (Oncopole, 31), un(e) Expert(e) en formulation solide et stérile , rattaché(e) à la Direction R&D Medical Care Pierre Fabre. Vous serez responsable du développement et de la fabrication de nouveaux candidats médicaments. Cela comprend la sélection et l’optimisation des formulations stériles et solides de petites molécules, le soutien à la fabrication, au processus de changement d'échelle et au transfert technologique du procédé de fabrication, la caractérisation des étapes de fabrication, la validation des activités de développement pour la validation, la définition des spécifications et la validation des processus. Plus précisément, vous : Proposez une stratégie pharmaceutique en relation avec son expertise CMC et vous vous assurez de la retranscription au sein des dossiers en tant qu’expert formulation. Vous assurez la revue qualité CMC (module 3) des dossiers produits et projets en tant qu’expert interne, et l’expertise du développement et du procédé de fabrication du produit pharmaceutique dans le cadre des Due Diligences. Vous vérifiez et validez les QOS et les variations demandant une expertise en galénique. Analysez et expertisez la problématique produit relative à la galénique et évaluez les travaux à réaliser pour y répondre. Assurez l’expertise galénique et de fabrication de toute demande, ainsi que la veille technologique et CMC. Vous êtes responsable du Work Package CMC pour les nouveaux projets en collaboration transverse avec les services cliniques, non-cliniques, recherche, réglementaire, qualité... Vous assurez du suivi des travaux en relation avec cette stratégie en termes de qualité/coût/délai auprès des métiers internes et des sous-traitants, et apportez le support d’expertise et de pilotage scientifique aux chargés de sous-traitance CMC Représentez l’expertise galénique de Pierre Fabre auprès des autorités en cas de questions. Vous rédigez et/ou vérifiez les parties CMC des IND/IMPD/NDA/MAA, y compris les questions-réponses aux autorités Définissez et gérez le budget de développement de formulation et de fabrication pour toutes les phases de développement Soutenez en tant qu'expert galénique les programmes internes de gestion du cycle de vie et les modifications réglementaires pour les actifs et les matières premières (c'est-à-dire changement d’équipement de fabrication, nouvelles sources de matières premières, optimisation du process de fabrication...). Ce poste est compatible avec du télétravail jusqu’à 2 jours par semaine. Nous offrons un package rémunération/avantages attractifs : Intéressement, participation, Actionnariat Pierre Fabre avec abondement, Mutuelle santé et prévoyance, 16 RTT en plus des CP, participation transport collectif, CE très attractif… Who you are ? Your skills at the service of innovative projects: Formulation engineer or PhD in Formulation 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 formulation, manufacturing process and project management associated with development programs is required. ------------------------------------------- Ingénieur formulation ou Doctorat en formulation/galénique Minimum 10 ans d’expérience dans de l’expertise CMC acquise au travers de plusieurs études cliniques (phase 1 à la phase 3), idéalement jusqu’à l’enregistrement. Anglais courant indispensable Vous bénéficiez d’une vaste expérience en matière de bonnes pratiques de fabrication (cGMP) Vous avez géré un CDMO Expérience nécessaire de direction technique en formulation, procédé de fabrication et de gestion de projets associés à des programmes de développement. At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.