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 coordination
* As 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 departments
* Assure the timely delivery of required documents (strategy plans, protocols and reports,…) as defined in the project plan
* Establish relevant change control proposals related to the projects (single or multi-site) with Site Project Manager (SPM) or Process Insight Associate Manager
* To 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 required
* Ensure that all process support activities are carried out at appropriate compliance levels
* Contribute and review the commercial product review document or campaign reports
* Leads 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 entities
* Ensure 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 personnel
* Provide training for new processes implementation, the Tech Transfer or new technology strategy
* Provide DP process expertise/innovation and enrich the current platform knowledge
Internal / External audits
* Ensure that above activities are auditable anytime
* Participate to internal/external audits
Who you are:
* Degree in Biotechnology, Process Engineering, Pharmacy or related subject.
* Experience in Drug product manufacturing
* Experience in R&D/Manufacturing environment (> 5 years).
* Experience in coordination of activities
* Experience in Extractable & Leachable, chemical compatibility, filter validation
* Sound awareness of bio-pharmaceutical business
* Sound awareness of GMP related issues and Health Authorities’ requirements
* Demonstrated success record in process improvements
* Demonstrated success record in position which interacts with other departments
* Must master and demonstrate ability to work in agile environment
* Fluent in French and English
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