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
• Bachelor of Science degree in manufacturing, biochemistry, organic chemistry, biology or another related technical degree
• 5+ years in manufacturing or manufacturing engineering; including NPI experience
• 3+ years of proven experience with DOE’s, high-speed automation or assembly equipment
• 3+ years’ experience with designing, specifying, implementing, and qualifying test methods
Preferred Qualification:
• Advanced degree in manufacturing, biochemistry, organic chemistry, biology or other related technical degrees
• Knowledge in Assay Development procedures for qualifying materials
• Experience with manufacturing in regulated environments including IQ, OQ and PQ documentation
• Experience with guard banding studies to test limits of test and develop acceptance criteria
• Experience with ANSI tables and statistical tools for sample size determination
• Strong analytical skills to explore data and develop engineering solutions
• Excellent written and verbal communication, ability to present and explain the design, defect data, metrics, supplier quality, improvement initiatives, and status to leadership
Responsibilities:
• Evaluate available technology in the industry and product requirements to develop assembly methods, processes, and equipment design to enable efficient manufacturing
• Use their knowledge of biological processes to develop test methods for material validation
• 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
• Develop process documentation such as work instructions, test procedures, quality control protocols, lot release protocols, and machine qualifications
• Develop test methods to validate test and quality control protocols
• Assist in setting manufacturing acceptance criteria for assay components, with guard
banding the concentrations and parameters
• Train personnel on manufacturing instruction and quality test protocols
• Train personnel as applicable and in the short term perform the builds to support scale-up
• Perform failure analysis to resolve production process issues such as non-conforming materials, yield, quality and throughput
Amazon Process Development Scientist
