Process Development Engineer, Oligonucleotide Manufacturing

Illumina, Inc.; San Diego (CA); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Access to genomics sequencing

Family planning

Health/dental/vision

Retirement benefits

Paid time off

Job summary

Illumina, Inc. is seeking a Sr Engineer - Process Development to join the Manufacturing Technology & Transfer team in the United States. The role focuses on developing and deploying oligonucleotide manufacturing processes and transferring them to production.

You will partner with development, Quality, Production and other engineering groups to enable scalable, compliant processes. The position requires extensive experience with oligonucleotide methods, cGMP, and DOE/ SPC techniques, along with

Qualifications

• Experience with oligonucleotide synthesis, purification and QC.
• Experience with cGMP and 21 CFR part 11 in FDA-regulated environments.
• Effective communication and ability to manage competing priorities.
• Strong collaboration across product development, quality and manufacturing.
• Experience with DOE and SPC techniques.

Responsibilities

• Execute feasibility and development oligonucleotide builds to support projects.
• Ideate and create manufacturing processes and define technical requirements for new production equipment.
• Author procedures and train production operators to manufacture product in a GMP environment.
• Troubleshoot yield, quality and throughput issues in product and process.
• Construct and execute DOE experiments to optimize processes and scale for production.
• Analyze test results, write reports and recommend process improvements.
• Coordinate with Product Development, Supply Chain, Manufacturing and Quality on NPI teams.

Skills

Oligonucleotide processes

DOE techniques

Statistical Process Control

Cross-functional collaboration

Education

Bachelor's degree in Chemistry or Biochemistry

Tools

Synthesis equipment

HPLC systems

MS instruments

UV spectroscopy

Job description

Illumina, Inc. is seeking a Sr Engineer - Process Development to join the Manufacturing Technology & Transfer team in the United States. The role focuses on developing and deploying oligonucleotide manufacturing processes and transferring them to production.

You will partner with development, Quality, Production and other engineering groups to enable scalable, compliant processes. The position requires extensive experience with oligonucleotide methods, cGMP, and DOE/ SPC techniques, along with