Description

 Work Your Magic with us!   Ready to explore, break barriers, and discover more? We know you-ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people-s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your role: The MSAT DP leads and manages all the Drug Products site technical activities within the compagny site to ensure the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.Evolving in this environment, DP Process Expert role is:To roll out and being DP process key contact point with the project stakeholders during the site activities for new product introductions (NPIs), technology transfer (TT), validation of Drug Product (DP) process or new product or process changes for commercial products.To ensure coordination of projects and production falling under the responsibility of DP MSAT and as agreed with the site Project Manager (SPM) or DP expert Associate Manager. ACCOUNTABILITY AREA Technical transfer / commercial manufacturing campaign activities coordinationAs part of DP process expert team, coordinate Process improvement for large scale manufacturing for multi-product projects (impacting different molecules).Implementation of new technologies, PATContribute to product strategy elaboration in collaboration with Site Project Manager (SPM) or DP expert Associate Manager and other departmentsAssure the timely delivery of required documents (strategy plans, protocols and reports,-) as defined in the project planEstablish relevant change control proposals related to the projects (single or multi-site) with Site Project Manager (SPM) or DP expert Associate ManagerTo ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP)-  Coordination of production troubleshooting/investigation and potential support, if requiredEnsure that all process support activities are carried out at appropriate compliance levelsContribute and review the commercial product review document or campaign reportsLeads major investigations in close collaboration with the DP expert Associate Manager & SPM & Validation expert, production and quality unit as well as pharma development when required Coordination with Pharmaceutical Development entitiesEnsure that due consideration is given to manufacturing requirements and potential issues as early as possible during the development of a process to be transferred and/or validated in production Training of the compagny personnelProvide training for new processes implementation, the Tech Transfer or new technology strategyProvide DP process expertise/innovation and enrich the current platform knowledge Internal / External auditsEnsure that above activities are auditable anytimeParticipate to internal/external audits Who you are: Degree in Biotechnology, Process Engineering, Pharmacy or related subject. Experience in Drug product manufacturingExperience in R&D/Manufacturing environment ( 5 years).Experience in coordination of activitiesExperience in Extractable & Leachable, chemical compatibility, filter validationSound awareness of bio-pharmaceutical businessSound awareness of GMP related issues and Health Authorities- requirementsDemonstrated success record in process improvementsDemonstrated success record in position which interacts with other departmentsMust master and demonstrate ability to work in agile environmentFluent in French and English What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!