Process Development Associate -Medical Devices, Senior / Level 4
Our Client, a major - Global Medical Devices company are looking to recruit for an experienced Products Development Associate 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.
The role will be based in the Process Transfer team in Manchester leading the creation and transfer of diagnostic assays and ancillaries from development and on market lifecycle stage to full production at the Manchester Facility and continuous improvement of existing processes.
- Leadership 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 and department SOPs.
- Typically requires BA or BS and 2 - 5 years related experience
- Project Management - experience in organizing their own and other's work to deliver projects to meet quality, budget and timeline requirements
- Working knowledge of experimental design
- Knowledge of current GMPs
- Blood Borne Pathogen training
- Interpersonal skills
- Technical skills
- Work under own initiative and uses own judgment
- Strong networking ability with multi-functional teams
- Problem Solving
- Advanced stills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint and Project)
- Strong math skills
- Applied knowledge of Technical writing