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We are seeking a candidate who can bring experience of clinical flow cytometry workflows to assist in new assays and reagents development. Uses independent judgment to adapt and modify standard reagent development techniques to solve difficult reagent challenges. Implements experiments independently and evaluates, discusses, presents and explains material of moderate to high complexity. Works under general direction, but independently resolves and defines approach to solutions. The candidate will be bringing a strong continuous improvement approach to reduce development cycles and streamline technology transfer from R&D into operations.
Job Responsibility:
Work with team members and lead collaborations across teams on crafting experimental approaches for new reagent and assay development
Maintain strong understanding of innovative science and technology development in the industry
Deliver clinical projects on schedule and within specification
Work with leadership team members and product development teams to improve time to market by reducing product development life cycle and improving the product development process
Prepare technical reports, summaries, protocols, and analyses of R&D projects
Work on issues where analysis of situation or data requires review of relevant factors
Exercise judgement within defined procedures and policies to determine appropriate action
Effectively coordinate with other functional areas associated with the R&D activities
Assure compliance with all local, state, federal, and BD policies/ procedures regulations associated with quality, regulatory, safety, etc.
Requirements:
Minimum Master’s degree or Ph.D. degree in biological science and a combination of education and experience in product development
Minimum 5 years of demonstrated experience in R&D or clinical/research laboratory environment
Experience in IVD product development is required
Strong, proven product development knowledge of processes, measures, etc. (phase gated development systems)
Knowledge of biostatistical methods and data analysis experience is required
Proven experience of working in cross-functional product development teams
Nice to have:
Experience with Flow Cytometry technology and experience in development of clinical Flow Cytometry assays
Knowledge of leukemia, lymphoma, and/or cancer biology