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Amazon Process Development Scientist Vacancy – Apply Online

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

Apply Online

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