Scientist, Product Transfer
Core
Lead the transfer of new qPCR-based molecular diagnostic assays from development to manufacturing, ensuring robust, reproducible, and scalable production of reagents.
Role type
Senior IC product transfer scientist (molecular diagnostics)
Builds
qPCR reagents and assay kits for early disease diagnosis and monitoring
Domain
Molecular diagnostics / qPCR assay manufacturing
Required skills
qPCR assay development and optimization, cGMP manufacturing, process validation, root-cause analysis, statistical design of experiments (DOE), contamination control workflows, regulatory compliance (FDA/ISO), project management
Preferred skills
immunoassay development, CLSI guidelines familiarity, AI tools for process automation
Technologies
Bio-Rad CFX, QuantStudio, LightCycler, Excel
Responsibilities
Lead NPI design transfer and complete Product Development Process requirements; Partner with Assay and Process Development to define assay requirements and design specifications; Characterize and optimize qPCR performance and reduce variability; Establish contamination-control workflows for nucleic-acid reagent manufacturing; Build reagents at scale for feasibility and design verification per cGMP; Plan and execute process verification; Mentor and train junior team members; Drive lean manufacturing and process improvements; Lead investigations and root-cause analysis; Review executed batch records and partner with QA on deviations and change control
Seniority
Mid-Senior, hands-on IC