exciting products for customers and collaborating with cross-functional teams. The person will be responsible for taking products and processes from concept feasibility through to implementation into production for com mercialization. In this position, the person will work closely with the R&D team(s) in demonstrating reagent feasibility, assay development, generating product specifications, characterizing the product, developing manufacturing and QC processes, and transferring these stable processes to Manufacturing.
The ideal candidate will have extensive experience with analytical technologies associated with molecular biology with an emphasis on commercial product development from
concept to manufacturing. The person will characterize reagents to meet manufacturing requirements for critical reagent consumables. Candidate should have strong hands-on laboratory experience, including molecular biology techniques, sample preparation, analytical assay development and preferably sequencing instrument operation.
Primary Responsibilities: Hands-on testing and integration of assay and process workflows onto sequencing platforms. Plan, conduct, analyze, interpret, and report recommendations based on tested experimental results. Support product commercialization from design transfer to manufacturing. backss information to ensure data sufficiency and completeness of results.
Write batch records, experimental protocols, summaries, and reports.
Source and qualify external vendors, develop specifications, set up supply chain and manufacturing process. Work in ISO 9001 and 13485 regulated environments. Position Requirements: Masters or Ph. D. in Molecular Biology, Biochemistry, or related relevant industry experience in Biochemistry or Molecular Biology, with emphasis on product development and testing. Prior experience with q PCR assay development, RNA sequencing is strongly desired. Deep understanding of biochemistry, next-generation sequencing, development of analytical and functional assays, DOE, sequencing data analysis. Hand-on scientist with experience in QC assay development and validation.
Skilled at writing batch records, validation reports, with experience in quality management system, risk analysis and mitigation.
