This opportunity would 6 (+) months of contract.
Job Description – The Scientist, Product Development will be responsible for developing new reagent products and the associated manufacturing and QC processes. Activities span from concept feasibility all the way through to installing the manufacturing and QC processes into manufacturing. These are reagent products associated with the ddPCR System and include reaction mixes, novel detection chemistries, reaction additives, control assays, oligos, emulsion oils and surfactants. This individual will be expected to complete hands on product development tasks with the objective of creating product specifications that meet specific application requirements. Then delivering validated processes to manufacturing that will ensure the supply and quality of these products. These tasks include investigation into new chemistries for feasibility, optimization of product specification, stability and verification testing of manufactured product to confirm that performance requirements are maintained. This will require the candidate to be highly productive in experimentation, results analysis and reporting.
The Scientist for Product Development is responsible for product and process development of chemistries used on the ddPCR platform. Job duties include but are not limited to:
• Identify and screen reaction components and conditions to establish concept feasibility. • Optimize and deliver the product specifications.
• Develop and optimize workflow protocols.
• Develop the manufacturing and QC processes from formulation through to finish packaged product. Transfer these processes to in-house manufacturing or outside manufacturing partners.
• Develop orthogonal analytical assays for product and component characterization.
• Productive execution of well thought out experiments, accurate recording of experiment and results, in depth analysis and reporting of results.
• Conduct stability, guard band, workflow variability and system verification testing to measure robustness of the product specified. • Use of Design of Experiment tools for product and process optimization Required Skills
• Hands on knowledge of the biochemistry of nucleic acid analysis methods (e.g. PCR, real-time PCR, ligation, restriction)
• Process development experience in the fields of PCR, Real time PCR or DNA Sequencing
• Knowledge of the state of the art with regards to amplification and detection technologies and capability
• Methods development capability for a broad range of standard techniques as well as ability to develop novel methods based on the requirements of the product. • Working knowledge of manufacturing infrastructure and process requirements • Excellent written and oral communication skills
• Quantitative skills and familiarity with statistical methods • Highly productive and reliable laboratory experimentation skills • Ability to deliver projects with aggressive schedules
Required – Education and Experience:
• MSc / PhD or equivalent capability in Molecular Biology, Biochemistry, Enzymology, Analytical Chemistry, or related discipline
• 2 + years of relevant industry experience developing and commercializing a successful product • Demonstrated ability to deliver novel products
Location – Pleasanton, California, United States