Description

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 AREATechnical 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, PAT Contribute to product strategy elaboration in collaboration with Site Project Manager (SPM) or Process Insight 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 Process Insight 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 Process insight 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