Responsible for developing real-time PCR and
RT-PCR assays to identify bacterial, viral, or fungal pathogens in clinical
specimens. Involved in all aspects of assay development including sample
preparation, nucleic acid isolation methods, design of highly multiplexed
real-time PCR and RT-PCR assays, creation and validation of test methods,
design transfer to production, and systems integration. Responsible for
analysis of complex datasets with appropriate statistical software.
Responsibilities also include writing and executing the Quality and
Manufacturing protocols for product transition from R&D to manufacturing
using design change/engineering change processes. Ensure that all design
requirements for the assay are met or exceeded and document each step of
development according to company protocols and SOPs.
Required Knowledge, Skills, and Abilities:
Master’s degree or foreign equivalent in Chemical Engineering, Biochemistry, Molecular
Biology or related field.2 years of experience in the job offered or in a related occupation
Must have experience in highly multiplexed PCR assays and real time PCR assays. Must have assay design and development experience. Must have commercial IVD (in vitro diagnostic) product development experience, GMP/GLP industry manufacturing experience and understanding of FDA regulations. Must have experience with integration of biological and instrument systems, DOE (Design of experiments) and statistical software.