Senior Engineer- Process Development at Illumina

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomics, Life SciencesIndustries

Requirements

Demonstrated ability to make oligonucleotides, nucleotides, and/or associated subassemblies
Manufacturing experience of organic synthesis is required
Knowledge and experience of scale-up chemistry, preparative and analytical chromatography, LC-MS and ability to interpret NMR is required
Working knowledge and experience of automated synthesis, manufacturing execution system (MES) and SQL is desirable
Experience in process support and development in a GMP environment
Strong analytical, problem-solving, troubleshooting, and root cause analysis skills
Strong interpersonal, verbal and written communication skills required
Must be detail oriented
Strong understanding of GMP is desirable
Experience with standard laboratory practices
High level computer skills are required. Programming knowledge is a plus
Experience with SAP or equivalent ERP system is desirable
Experience working in an ISO 13485 or FDA regulated environment is desirable
Experience with lean manufacturing

Responsibilities

Provide technical leadership in the production and analysis of oligonucleotides, modified/functionalized Nucleotides, in a regulated manufacturing environment
Collaborate with cross-functional teams to both (1) address operational sustaining needs (i.e. resolve production issues related to safety, yield, quality, and/or throughput) and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products
Represent and advocate for Operations’ needs in cross-functional meetings to ensure quality, continuity and efficiency of products and processes transferred to and implemented within manufacturing teams
Utilize change management practices to drive safety, quality, efficiency, and/or cost improvements
Identify, analyze trends, monitor and update Manufacturing KPIs and metrics
Lead or support non-conformances/CAPA’s through technical evaluations and investigations
Identify, drive and support continuous improvement and sustaining activities
Select appropriate components and vendors in area of responsibility, without oversight
Lead and support teams in the transfer of manufacturing processes between manufacturing locations
Responsible for productive cross-site and cross-functional relationship between manufacturing sites
Execution of manufacturing builds when needed to support Development, Pre-Production and Production orders
Plan and prioritize assigned tasks and activities with minimal guidance
Execute tasks independently and with guidance as necessary from project lead or manager
Influence technical decisions in own area of responsibility
Track component COGS and associated project expenses

Skills

Process Development

Oligonucleotides

Nucleotides

Manufacturing

Technical Leadership

Cross-Functional Collaboration

Yield Improvement

Quality Control

Production Processes

Regulated Manufacturing

New Product Introduction

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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