Engineer 1 - Process Development jobs in United States
cer-icon
Apply on Employer Site
company-logo

Illumina · 17 hours ago

Engineer 1 - Process Development

Illumina is a company focused on expanding access to genomic technology to promote health equity. The Engineer 1 - Process Development will be part of the Manufacturing Technology & Transfer team, responsible for developing and deploying oligonucleotide manufacturing processes while collaborating with various teams to ensure successful project execution.

BiotechnologyGeneticsHealth CareMedical
badNo H1Bnote

Responsibilities

Execute feasibility and development oligonucleotide builds as necessary to support various projects timelines
Define technical requirements for manufacturing processes and new production equipment
Author procedures and instructions for new manufacturing processes and train production operators to manufacture product in a GMP environment
Troubleshoot new product and manufacturing process issues related to yield, quality and throughput
Develop understanding of CPM (critical parameter management); construct and execute controlled experiments including DOE's to optimize processes and scale; address yield/quality issues and drive implementation of solutions into a production environment to meet project goals
Analyze process test results, contribute to reports and inform technical recommendations to improve product and process quality
Work cross functionally with Product Development, Supply Chain, Manufacturing, Quality, EHS and Facilities teams to enable operations for both launch and final scale manufacturing
Ensure successful transfer of knowledge into manufacturing and the sustaining support teams

Qualification

Oligonucleotide processesProcess developmentCGMP experienceStatisticsProject managementEffective communicationOrganizational skills

Required

Experience with some and ideally all oligonucleotide processes (synthesis, cleavage/deprotection, purification, desalting, and in-process and final QC) and equipment (synthesizers, preparative HPLCs, analytical HPLCs, MSs, UV Specs, etc)
Demonstrated ability to accomplish goals while working across departments
Effective communication (both verbal and written) and organizational skills to manage competing project priorities
B.S. or M.S. in Chemistry, Biochemistry, Chemical Engineering, or equivalent, with 0-3 years of relevant industry experience in oligonucleotide manufacturing/support, process development, scale-up, and process improvement

Preferred

Experience with liquid handlers and ERP systems is a plus
Experience with Statistics, Statistical Process Control and DOE techniques is a plus
Experience with cGMP and 21 CFR part 11 and supporting manufacturing in an FDA regulated environment is preferred
Experience with high volume production in a high tech consumables industry is a plus
Experience with product development processes and project management is a plus

Benefits

Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off

Company

Illumina

company-logo
Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.

Funding

Current Stage
Public Company
Total Funding
$1.28B
Key Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO

Leadership Team

leader-logo
Steven Barnard
Chief Technology Officer, Head of Research & Product Development
linkedin
leader-logo
Jenny Lei Zheng
SVP & GM of Greater China
linkedin
Company data provided by crunchbase