
Technology Transfer & Manufacturing Project Manager
- Eigenbrakel, Waals Brabant
- Vast
- Voltijds
- Execute technology transfer and upscale projects, in close collaboration with the company cross-functional teams (MSAT, External Manufacturing, Industrial & Analytical Leads, Quality, Regulatory etc.) and CMO.
- Depending on the type of project, act as project manager or project team member.
- Review and approve all project documentation (protocols, reports, risk assessments, forms,…)
- Regularly track the project's progress (timing, activities, resources, costs) against the plan and adjust as needed
- Collaborate with the Quality team to ensure product quality and consistency, and manage deviations and change controls
- Ensure manufacturing processes comply with regulatory requirements and industry standards
- Edit CPV reports for the company products manufactured at the CMO and tested by the company
- Participate in projects (upscale, technology transfer): assist to internal and external meetings, review/approve project documentation, manage deviations and change controls, report project progress internally
- Provide the technical expertise to support the company's CMO to ensure effective processes
- Implement project management best practices throughout the project
- Master's degree in engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of experience in pharmaceutical manufacturing processes.
- Technical and industrial expertise in sterile pharmaceutical products.
- Experience in managing technology transfers.
- Experience with compliance in a GMP environment.
- Experience in project management
- Fluent in French & English (written and spoken)
- Subject matter expert in technical / manufacturing aspects related to sterile DP compounding and filling activities
StepStone
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