Apply laboratory techniques and skills to assist in experimental design and execution in support of new product development. Responsible for development of IVD HLA nucleic acid assays for application on multiple platforms, including Next Generation Sequencing, Sanger Sequencing, and Gel Electrophoresis, with the initial focus on Gel Electrophoresis.
This individual will independently conduct scientific experiments using laboratory equipment and calculations. Troubleshoot experiments; identify and solve problems in experimental design.
Understand and support New Product Introduction by impacting the business opportunities through successful completion of tasks and projects and by providing suggestions for improving products and processes
- Experience with development of heavily multiplexed PCR reactions, including primer design, sample purification, multiplexed amplification, and data analysis.
- Familiarity in performing queries in BLAST or other sequence database.
- Ability to learn, become proficient, and contribute to development of data analysis software.
- Experience developing an FDA 510k and/or Pre-market Approval (PMA) registered molecular diagnostic product, including collaborating with regulatory, V&V, and manufacturing teams on necessary testing, documentation, and supporting manufacturing scale-up.
- Above average communication skills, ability to network for information and support across multiple sights, and to provide global field support.
- Prior experience using and/or developing HLA assays
- Prior experience supporting FDA registered products, including testing and documentation in support of complaint handling
- Prior experience developing IVD products for CE-IVD and other international regulatory bodies
Requires a Bachelorís degree in molecular biology, or other related discipline, with a minimum of five years industrial experience including assay development following Good Laboratory Practices (GLP). Masters degree in a specific scientific discipline is desired.
|Life Technologies, Inc.|
State or Province