Role: Products Process Transfer / Development - Medical Device
Salary: Competitive, plus additional bonus
Hours: Days - Monday/ Friday
Our Client, a major - Global Medical Devices company are looking to recruit for an experienced Products Transfer Scientist, who will work at their modern; European Hub based in Manchester with manufacturing and R&D innovation onsite. This person will play a key part of development and the transfer or product applications and technology.
- Supports and sometimes leads in the efforts to scale up, optimize, validate and transfer bulk, fill and lyophilization processes to production.
- Management of project plans and timelines, with use of Microsoft Project and ability to highlight and problem solve issues during project completion.
- Lead project meetings, with a clear agenda and meeting minutes.
- Assists in the development of manufacturing processes for transfer to Manufacturing
- Authoring of project documentation, for instance Validation Protocols, Master Validation Plans (MVPs), Quality Plans (QPLs) and Master Validation Reports (MVRs).
- Trains others on newly developed procedures
- Independently produces notebook, pilot and production materials
- Keeps accurate records and documentation
- Extensive understanding of working within a quality management system that conforms to the ISO13485 standards, including authoring SOPs and Manufacturing instructions when required and/or Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs
- Typically requires BA or BS and 1 - 3 years related experience desired or MS with 0 - 1 years' experience desired
- Project Management - experience in organizing their own and other's work to deliver projects to meet quality, budget and timeline requirements
- Knowledge of GMP/GLP
- Interpersonal skills
- Technical skills
- Strong networking ability with multi-functional teams
- Advanced stills in MS Office packages (e.g. Excel, Word, Outlook, and PowerPoint)
- Problem Solving
- Applied knowledge of Technical writing