Director of R&D Microbiology
Cartwright James is currently working with a Multinational IVD Company who has an innovative Microbiology Product Portfolio alongside a strong innovation pipeline. This company is seeking a Director of R&D to provide functional excellence, leading the delivery of novel and market-leading microbiology solutions.
My client is seeking a strong front-runner and technical expert with a proven track-record in leading the commercial development of Microbiology assays, particularly within antibiotic sensitivity testing and blood culture automation. Playing an instrumental part in a cross-functional senior management team, this individual will drive the discovery of innovative solutions to complex Microbiology problems.
- Leading planning, resource allocation/management and on-time and budget delivery of R&D throughout the Microbiology unit, specifically throughout Blood Culture, Clinical Microbiology or Laboratory Automation.
- Coordinates functional aspects of multiple highly-complex, business critical, cross-functional programs, working specifically alongside Regulatory and Quality throughout implementation of ISO13485 standards and FDA/CE-IVD launch and pre-submission.
- Providing domain expertise throughout the Microbiology, specifically including laboratory workflow, microbial metabolism, growth media formulation, statistical modelling and data analysis.
- Leads an extended team of up to 45 with 5 directly reporting Technical Managers and Senior Managers.
- Maintains up-to-date expertise within the field of clinical microbiology specifically related to current products, approaches, regulatory requirements and clinical applications and representing the business in internal and external matters.
- Key contributor to opportunity assessment, strategic visioning and technical aspects of intellectual property, providing technical updates and recommendations to the Leadership team as requested.
- Specific and detailed knowledge of either Blood Culture, Antibiotic Susceptibility Testing or Microbial Identification.
- PhD in Life Sciences or equivalent preferable, with BSc a necessity.
- Microbiology product launch experience alongside a proven track-record in the development of IVD assays.
- >5 years’ leadership experience.
- Proven knowledge of end-to end product development including feasibility, design, development transfer, support of regulatory and clinical submission process and commercial launch.
- Experience working directly with FDA and CE-IVD regulations.
Cartwright James is a global executive search and selection company based in the UK, providing expert knowledge and bespoke services in the international Chemicals, Medical and Scientific markets. We receive a vast volume of applications for each position, therefore it takes time to assess each candidate. We will be in touch if the candidates experience matches the job requirements.