Amazon Process Development Scientist Vacancy – Apply Online
Amazon is looking for a Scientist, Process Development to join an exciting new project team working to build a completely new, best in class product. Our organization rewards intellectual curiosity while maintaining the direct-to-market product focus.
The ideal candidate will have experience transferring and scaling reagent and assay products with a laboratory skillset in biological fields. Will lead the development of line layouts for reagent builds and develop methods to validate and lot release product. They must enjoy problem-solving, cross-functional collaboration and possess practical hands-on knowledge of process equipment and product lot release.
Job Title: Scientist, Process Development
Job ID: 1756923
Location: US, CA, Milpitas
Eligibility Criteria
โข Bachelor of Science degree in manufacturing, biochemistry, organic chemistry, biology or another related technical degree
โข 5+ years in manufacturing or manufacturing engineering; including NPI experience
โข 3+ years of proven experience with DOE’s, high-speed automation or assembly equipment
โข 3+ yearsโ experience with designing, specifying, implementing, and qualifying test methods
Preferred Qualification:
โข Advanced degree in manufacturing, biochemistry, organic chemistry, biology or other related technical degrees
โข Knowledge in Assay Development procedures for qualifying materials
โข Experience with manufacturing in regulated environments including IQ, OQ and PQ documentation
โข Experience with guard banding studies to test limits of test and develop acceptance criteria
โข Experience with ANSI tables and statistical tools for sample size determination
โข Strong analytical skills to explore data and develop engineering solutions
โข Excellent written and verbal communication, ability to present and explain the design, defect data, metrics, supplier quality, improvement initiatives, and status to leadership
Responsibilities:
โข Evaluate available technology in the industry and product requirements to develop assembly methods, processes, and equipment design to enable efficient manufacturing
โข Use their knowledge of biological processes to develop test methods for material validation
โข Facilitate and support the transfer of assay, manufacturing, and quality processes from development through volume production in a regulated environment while working closely with Assay, Engineering and Quality team members
โข Develop process documentation such as work instructions, test procedures, quality control protocols, lot release protocols, and machine qualifications
โข Develop test methods to validate test and quality control protocols
โข Assist in setting manufacturing acceptance criteria for assay components, with guard
banding the concentrations and parameters
โข Train personnel on manufacturing instruction and quality test protocols
โข Train personnel as applicable and in the short term perform the builds to support scale-up
โข Perform failure analysis to resolve production process issues such as non-conforming materials, yield, quality and throughput
Amazon Process Development Scientist
