Our client is developing revolutionary medical devices and technologies for the Diagnostic sector. Seeking an experienced R&D Manager.
- You will lead a project team to develop and deliver diagnostic assays to meet the product requirements for launch in line with the company's goals and timelines.
- You will be responsible for the technical leadership of the project as well as the continuous growth and development of the projects scientific team.
Key roles and Responsibilities
- Leading the development of individual assays from concept through Design Freeze and Transfer to Production to Launch following our Design and Development process incorporating Design for Manufacture(DFM) approach.
- Run the daily cross functional project meetings incorporating Voice of Customer.
- Managing internal and external partners to support the assay development.
- Developing a robust assay system through product characterisation, risk management and testing to failure.
- Ensuring that the developed assay and its components are capable of meeting the required performance, stability and cost requirements for the assay platform.
- Ensuring Design Control procedures are adhered to and generate project deliverables such as:
- Design & Development Plans
- Product Requirement Documents
- Design History Summary report
- Pre Validation and Verification Plan
- Ensuring GDP, GLP and GMP standards are maintained.
- Degree qualified in a relevant scientific discipline
- Detailed knowledge and understanding of factors which drive Immunoassay performance (such as stability, precision, sensitivity, accuracy)
- Experienced in root cause analysis and technical problem solving.
- Experience of working to ISO 13485 or FDA 21CFR, part 820 (or similar)
- Experience and knowledge of requirements to launch an in-vitro diagnostic product (validation and verification, FMEA, control solutions, on-board controls, etc.)
- Experience of leading multiple R&D projects, from proof of concept to product launch.
- Experience of leading technical and project teams of varying sizes
- Experience of using particle-based immunoassays.
- Experience with fluorescent technology
- Experience of optimising formulations for drying reagents for use in POC immunoassays
- Experience with launching IVD products in multiple geographies (US, EMEA, China)
If you have any questions, want to know more or wish to apply, please contact me.
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