Assay Developer - qPCR - IVD Molecular Diagnostic Assays
REQUIRES RELOCATION to a rapidly up and coming Southern Research Region surrounding a Research University City where beautiful new homes are available at fantastically low price, taxes are some of the lowest in the nation and the well paid professional community supports record breaking public elementary and high school educations.
Support development and commercialization of In Vitro Device molecular diagnostic assays.
*** Utilize PCR nucleic acid amplification technologies to develop and qualify In Vitro Device Diagnostic assays under established Design Control Quality Systems.
*** Author and execute reagent verification and validation protocols. Ensure assays meet product design and performance requirements.
*** Develop and validate Quality Control testing methods, establish material specifications, and process acceptance criteria.
*** Establish and complete shelf-life studies for FDA submission.
*** Develop final manufacturing documentation and transfer reagent processes to internal and external manufacturing organizations for FDA approved assays.
*** Create work plans to ensure timely completion of product development, verification, and validation under quality system.
*** Conduct process optimization and identify opportunities for process improvement and control.
*** Provide technical guidance related to real-time PCR chemistry instrument usage, such as TaqMan Molecular Beacon, and plate-based real time instrumentation.
*** Serve as subject matter expert related to oligonucleotide primers and probes; enzymes; buffers; dNTPs (deoxyribonucleotide triphosphate); hybridization buffers; external controls; inhibition controls; DNA & RNA purification; microscopy; and similar.
Highly innovative organization with cutting edge research capabilities offers an industry competitive compensation package, tuition reimbursement, bonuses, full medical benefits, 401(k) retirement plan, life and disability insurance, numerous professional development opportunities, generous paid vacation
Please reference #37861366 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 2-5 yearsJob City Location: St LouisJob State Location: MOJob Country Location: USA