Formulation Expert in solid & sterile pharmaceutical forms - CDI (H/F)

Formulation Expert in solid & sterile pharmaceutical forms - CDI (H/F)

Formulation Expert in solid & sterile pharmaceutical forms - CDI (H/F)

Location: Haute Garonne (31)

Time Type: Temps plein

Posted on: Offre publiée hier

Job Requisition ID: JR108838

Qui sommes-nous ?

Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France.

Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.

Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue d’utilité publique, et secondairement par ses collaborateurs à travers un plan d’actionnariat salarié.

En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau « Excellence ».

Pierre Fabre est reconnu comme l’un des « Meilleurs Employeurs du Monde 2021 » par Forbes. Notre groupe est classé dans le Top 6 de l’industrie cosmétique et dans le Top 7 de l’industrie pharmaceutique dans le monde.

Votre mission

We are recruiting a Formulation Expert in solid and sterile forms 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 pharmaceutical forms (Drug Product formulation), manufacturing support, scale-up process and technology transfer of the Drug Product (DP), characterization of the DP process steps, validation of development activities for validation, definition of specifications and validation of processes.

More specifically, you will:

• Propose a pharmaceutical strategy in line with its CMC formulation 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 formulation expertise as part of Due Diligences.
• You review QOS and variations requiring CMC formulation expertise.
• Analyze and appraise product issues relating to formulation, and assess the work required to resolve them.
• Provide formulation expertise for all requests (development and manufacturing), 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 formulation and manufacturing budget for all development phases.

This position is compatible with teleworking up to 2 days a week.

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...

Qui êtes-vous ?

Education-Experience :

Formulation engineer or PhD in formulation/Galenic

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 and project management associated with development programs is required.

Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction.