Vacancy expired!
- Serve in technical and project leadership roles in developing molecular diagnostic assays.
- Work within the laboratory environment to optimize assays.
- Design, optimize, and verify primers, probes, reagent formulations and controls; ensuring that designs achieve product requirements.
- Maintain QSR compliance of project documentation and processes.
- Partner with Microbiology, Engineering, Quality and Manufacturing on cross-functional core teams.
- Design, review, and analyze multifactorial optimization experiments including DOEs.
- Lead and conduct drafting of documentation including protocols, reports, risk analyses, batch records and other project documentation.
- Effectively plan, resource and achieve milestones and timelines.
- Ph.D or M.S. in a Physical or Life Sciences discipline.
- PhD with 1 year experience OR MS with 5+ years of experience in molecular diagnostic assay development required.
- Experience developing and/or supporting FDA cleared IVD products strongly preferred.
- Must have a solid understand of molecular assay design and optimization.
- Demonstrated technical expertise in Molecular Diagnostic assays (PCR, qPCR, sequencing, etc.); preferably multiplex PCR assay design with expertise in primer design and reaction optimization.
- Knowledge of scientific and quality aspects of IVD product development.
- Demonstrated experience working under design controls, risk management and QSR compliance and in developing clear work instructions, protocols, reports and other documentation.
- Ability to learn new technologies, address complex technical problems and identify solutions with strong attention to detail.
- Must demonstrate a high level of commitment to delivering on timelines and milestones to achieve business objectives.
- Proficient with statistical analysis methods and software a plus, understanding of DoE a plus.
Vacancy expired!