- 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.
Skills and Experience:
- 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.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Location/Region: Arlington Heights, MA