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MedinCell® is a pharmaceutical company at commercial stage that develops innovative long-acting injectable medicines in many therapeutic areas based on our BEPO® technology. We are looking for a Senior Process Development Engineer to join our Process Development and Manufacturing team which main mission is to scale-up formulation until manufacturing process intended for clinical batches. The team also design equipment for manufacturing process and drive their management including outsourced activities. Missions Process Development and Manufacturing • Deploy process and technology transfer for manufacturing of injectable formulations through scale-up to GMP clinical stage Contract Development & Manufacturing Organizations (CDMOs)., • Conduct scientific literature search to solve problems and make recommendations for manufacturing process improvement., • Provide technical input into the creation of CPP (Critical Process Parameters) and CQA (Critical Quality Attributes) for each project., • Design process development activities., • Perform process optimization and define optimal sterilization process for drug products in vials, prefilled-syringes and/or cartridges., • Assess and implement optimal process conditions to ensure in-process stability of the drug products., • Ensure that technology transfer targeted milestones are achieved on time and Quality., • Foresee logistics for experiments; conduct experiments; summarize and assess reported results to help decision-making process on next project steps., • Establish effective working relationships with CDMOs in support of Product Transfer activity to CDMOs., • Be responsible for industrial engineering standards and application to capital investments, for facility and equipment utilization, and for operational efficiencies., • Contribute and entable the engineering function to deliver from the design, conception and strategy implementation for both internal and external resources. Quality Assurance • Ensure that the operational processes for Process Development and Manufacturing of drug products are aligned with the safety and operational standard procedures of the company and the regulatory requirements., • Assure the traceability of the data to ensure their integrity and their auditability., • Highlights appropriate resources to support the management of process equipment included maintenance and to ensure relevant training to the leader., • Select appropriate vendors for what regards management of equipment including maintenance., • Ensure that any quality event (e.g. deviation, HSE issue) occurring during the realization of the technical activities or during check of the fit-for-purpose fullness of process equipment is reported according to the company’s SOPs., • Maintain updated knowledge of relevant guidelines and regulatory requirements in all phases of development., • Maintain high standard documentation and effective records of all technical activities in dedicated worksheets (paper and/or electronic)., • Contribute in establishing Requests for Proposals for Process activities. Profile Experience • Minimum of 5 years of experience in process development, engineering, technology transfer, scale-up and GMP clinical manufacturing of liquid sterile injectable drug products., • Experience in long-acting injectables would be a plus., • Previous engineering experience of a process development and transfer activities for injectable pharmaceutical products. Qualifications • Minimum of a Master’s degree in chemical engineering, process engineering and development or similar., • Expertise in many manufacturing processes and equipment size from pilot to commercial scale., • Knowledge of the critical activities and success factors required for an effective and efficient technology transfer., • Knowledge of concepts, sequencing, and documentation of commissioning and qualification activities required by design intent. Languages • French and Fluent in English, spoken and written ability to attend complex meetings and write clear reports. Additional skills • Strong knowledge in regulatory requirements, pharmaceutical guidelines, and international standards, mainly in injectable products., • Experienced in compounding raw materials and manufacturing drug products., • Results orientation with focus on timely delivery and sense of urgency., • Ability to make choices within budget and priorities., • High degree of autonomy.

A propos de Nous : Depuis 20 ans, les plus grands laboratoires nous renouvellent leur confiance. Spécialisés en pharmaceutique, biotechnologies et dispositifs médicaux, nous accompagnons nos clients de la recherche jusqu’à la mise sur le marché de leurs produits. Société à taille humaine, nous avons à cœur d'accompagner et de faire progresser personnellement nos 600 collaborateurs reconnus pour leur expertise technique et scientifique. A travers nos filiales régionales, nous garantissons à chacun une stabilité géographique, sans clause de mobilité sur les principaux bassins d’activités en France, Belgique, Suisse et Canada. Chez Consultys, nous prouvons qu’il est possible d’accorder Humain et Performance. Bien plus que des concepts, nos 3 valeurs "Respect, Reconnaissance et Transparence" nous guident et sont le socle de notre histoire, le cœur du succès de notre groupe. Description du poste : CONSULTYS recrute un PMO (F/H) pour assister notre client de l'industrie pharmaceutique dans le transfert et l'installation d'une nouvelle ligne de production aseptique. Vous aurez pour missions : • Planifier et gérer le projet de transfert et d'installation de la nouvelle ligne de production aseptique en collaboration avec l'équipe projet du client., • Assurer la gestion de la portée, des coûts, des délais et des risques du projet., • Superviser la mise en œuvre des plans de projet et veiller à leur alignement avec les objectifs stratégiques du client., • Élaborer et maintenir des rapports d'avancement pour la haute direction du client. A propos de Vous : • Diplôme universitaire en ingénierie, sciences de la vie ou toute autre discipline pertinente., • Minimum de 5 ans d'expérience en gestion de projet, y compris en tant que PMO., • Connaissance approfondie de MS project et/ou Primavera., • Excellentes compétences en communication et en relations interpersonnelles., • Capacité à travailler de manière autonome et à gérer plusieurs projets en même temps., • Expérience dans l'industrie pharmaceutique ou biotechnologique (un atout). Envie d’intégrer l’univers du conseil au sein d’une société à taille humaine valorisant l’individu et la performance ? De vous investir à long terme sur des projets innovants ? De partager vos compétences au sein d’une équipe soudée où les expériences se partagent librement ? Alors Rejoignez-Nous ! CONSULTYS est ouvert à tous les talents et s’engage en faveur de la diversité et de l’inclusion des personnes en situation de handicap.

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