Responsibilities -
- Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems.
- Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for packaging process practices. This includes investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into packaging and Pharma manufacturing systems.
- Provide both technical and project management support as needed for CMC and packaging projects in the perimeter of MSAT in support of late stage NCE development, Life Cycle Management Programs (LCM) and Commercial Products.
- Support multi-functional teams to formulate plans and strategy that meets the defined objectives.
- Collaborate with R&D Drug Development, iCMC, IA packaging sites, component, material and equipment suppliers, Regional Marketing, Regulatory, Supply Chain, and QA in the development of project strategies and objectives.
- Lead or support the qualification (IOQ/PPQ) of process and packaging and primary and secondary equipment
- Lead or support the qualification of transport systems for bulk / intermediates and finished products to established.
Qualifications
• Bachelor's Degree/Undergraduate Degree or Advanced Degree in Process/Package engineering