Position Title: Senior Director or Vice President of Assay Development
Description: Velox is seeking a senior level R&D leader to manage and carry out the development of assays within our novel molecular diagnostics platform. Candidate will be expected to lead the development of our assays independently and manage our in-house assay development group. Candidate will be expected to collaborate effectively with our instrument development team, as well as with third party contract design & manufacturing groups to integrate assays into the instrument platform. Velox is seeking motivated, self-sufficient individuals, with extensive experience in the development of FDA-approved molecular diagnostic assays who will work tenaciously to achieve the development goals of the company. Candidate will work with senior level Velox staff to outline assay and product requirements and review progress regularly. Candidate will report directly to the CEO.
- Own the assay development process. Specifically, work with the instrument development team and other technical teams to produce assay specifications. Responsible for the assay specifications.
- Lead assay development activities, manage internal technical teams, and/or external contract development companies.
- Collaborate with internal technical teams and consultants to perform verification and validation of Velox’s molecular diagnostics product.
- Ph.D. in Molecular Biology, Microbiology, or similar
- Strong track record of successful management of in vitro molecular diagnostic assay development. At least 5 – 10 years of industry experience in designing and developing IVD assays for FDA approved products. Experience with molecular diagnostic instrument design, development, and integration will be a plus. Specifically:
- Experience with design and development of modern molecular assays (traditional, quantitative real-time, and reverse transcription PCR, digital/droplet PCR, DNA microarray, etc.). Working knowledge of PCR primer and probe design and experience with design software such as SnapGene, Benchling, or APE.
- Experience with basic microbiology techniques such as bacterial culture, etc.
- Experience with statistical techniques for experimental design and data analysis
- Experience with product development within quality systems, design control procedures, and other FDA regulations
- Experience of taking a project from conception, through product development, and all the way to FDA approval
- Experience with fluorescent microscopy and understanding of fluorescence principles, digital signal acquisition, processing, and analysis
- Experience with microfluidics, fluid handling, and biological sample processing
- Previous experience collaborating with and managing contract development and manufacturing companies preferred
Compensation: Commensurate with experience
Interested candidates please Apply Here. Full job description can also be viewed Here.
Questions regarding the position can be directed to: firstname.lastname@example.org.
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