Formulation Expert in solid sterile pharmaceutical forms - CDI HF
Formulation Expert in solid sterile pharmaceutical forms - CDI HF
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Job Description
Who we are
Pierre Fabre is the 2nd largest dermocosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.
Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avne Klorane Ducray Ren Furterer ADerma Naturactive Pierre Fabre Oral Care.
Established in the Occitanie region since its creation and manufacturing over 95 of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86 of the Pierre Fabre Group is held by the Pierre Fabre Foundation a governmentrecognized publicinterest foundation while a smaller share is owned by its employees via an employee stock ownership plan.
In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.
Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.
Your 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 Cares 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 scaleup 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 inhouse 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 crossfunctional collaboration with clinical nonclinical 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 Fabres 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
- Support as formulation expert internal life cycle management programs and regulatory changes for DP and raw materials (i.e. equipment changes new sourcing of raw material manufacturing process optimization .
This position is compatible with teleworking up to 2 days a week.
We offer an attractive remuneration/benefits package: Incentives profitsharing 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 strile rattach(e) la Direction R&D Medical Care Pierre Fabre.
Vous serez responsable du dveloppement et de la fabrication de nouveaux candidats mdicaments. Cela comprend la slection et loptimisation des formes pharmaceutiques (formulation du produit fini) le soutien la fabrication au processus de mise lchelle et au transfert technologique du produit fini la caractrisation des tapes du procd de fabrication la validation des activits de dveloppement la dfinition des spcifications et la validation des processus.
Plus prcisment vous :
- Proposez une stratgie pharmaceutique en relation avec son expertise en formulation et vous vous assurez de la retranscription au sein des dossiers en tant quexpert CMC. Vous assurez la revue qualit CMC (module 3 des dossiers produits et projets en tant quexpert en interne et lexpertise en formulation dans le cadre des Due Diligences.
- Vous vrifiez les QOS et les variations demandant une expertise CMC.
- Analysez et expertisez la problmatique produit relative la formulation et valuez les travaux raliser pour y rpondre.
- Assurez lexpertise en formulation (dveloppement et fabrication) de toute demande ainsi que la veille technologique et CMC. Vous tes responsable du Work Package CMC pour les nouveaux projets en collaboration transverse avec les services cliniques noncliniques recherche rglementaire qualit...
- Vous assurez le suivi des travaux en relation avec cette stratgie en termes de qualit/cot/dlai auprs des mtiers internes et des soustraitants et apportez le support dexpertise et de pilotage scientifique aux chargs de soustraitance CMC
- Reprsentez lexpertise CMC de Pierre Fabre auprs des autorits en cas de questions. Vous rdigez et/ou vrifiez les parties CMC des IND/IMPD/NDA/MAA y compris les questionsrponses aux autorits
- Dfinissez et grez le budget formulation pour toutes les phases de dveloppement
- Soutenez en tant quexpert en formulation les programmes internes de gestion du cycle de vie et les modifications rglementaires pour les produits finis et les matires premires (cestdire valuation du changement dquipement nouvelles sources de matires premires optimisation du procd de fabrication....
Ce poste est compatible avec du tltravail jusqu 2 jours par semaine.
Nous offrons un package rmunration/avantages attractifs : Intressement participation Actionnariat Pierre Fabre avec abondement Mutuelle sant et prvoyance 16 RTT en plus des CP participation transport collectif CE trs attractif
Who you are
EducationExperience :
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.
Ingnieur en formulation ou Doctorat en formulation/Galnique
Minimum 10 ans dexprience dans de lexpertise CMC acquise au travers de plusieurs tudes cliniques phase 1 la phase 3 idalement jusqu lenregistrement.
Anglais courant indispensable
Vous bnficiez dune vaste exprience en matire de bonnes pratiques de fabrication (cGMP)
Vous avez gr un CDMO
Exprience ncessaire de direction technique en formulation et de gestion de projets associs des programmes de dveloppement.
We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.
Employment Type
Full-Time
