Senior Scientist

What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Illumina Laboratory Services (ILS) is an exciting and rewarding organization that applies Illumina’s core sequencing and array technology to sustain existing Illumina’s service offering while driving implementation of new assays and technologies into clinical laboratory service offering. ILS works cross functionally to meet customer demands while also exploring new offerings within the clinical space. The Sr. Scientist role in the development and validation team of Illumina Laboratory Services will work on the development and validation of a wide range of workflows and processes for clinical and research use in the genomics and multiomics spaces. This role will work closely with the automation development, software development, bioinformatics, process engineering, quality assurance, and operations groups. This role also will be involved in a cross-functional, cross-site collaborative team to transfer new tests and improve existing tests in Illumina’s clinical laboratory, write technical documents, and plan/execute experiments for use in development studies and validations. The ideal candidate will be able to lead appropriate multi-disciplinary investigations and resolve technical problems, have experience interfacing with cross functional teams and familiarity with the regulatory standards of clinical laboratory environment. In addition, experience in molecular biology methods for nucleic acid applications and sequencing are required. Responsibilities:

• Support development and validation efforts in CLIA, CAP and ISO13485 compliant environment.
• Lead laboratory experiments, design, and execution, analyze data, and write development and validation plans/reports as appropriate.
• Ability to apply DOE methods, and collect requirements, plan activities, and contribute to budget of allocated project scope, and prioritization of activities/assignments to supporting team members.
• Facilitate the transfer of NGS and/or Array technologies from development to the CLIA laboratory.
• Collaborate with cross-functional groups including QA, Software, Bioinformatics, Process/Automation engineers, Supply chain, and Operations to launch new workflows and improve existing lab processes.
• Support and provide guidance on technical issue resolution.
• Work across a wide range of technologies, such as sample preparation, library prep, and next-generation sequencing.
• Support in training laboratory staff on new workflows/protocols.
• Be a technical and integration representative for Operations on cross functional initiatives.
• Support and troubleshoot existing processes and may provide guidance on potential enhancements as appropriate.

All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities. Requirements:

• Typically requires a minimum of 5+ years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Ph.D. in Molecular Biology, Genomics, Genetics, or Biochemistry with experience in a laboratory environment performing research or development activities in an academic or industrial setting is preferred
• Knowledge and hands-on skills working with a variety of molecular techniques such as NGS, PCR, and microarrays.
• Excellent skills in experimental design, implementation, troubleshooting, and data analysis.
• Demonstrated ability for technical proficiency, scientific creativity, and independent thought.
• Ability to quickly learn new scientific technologies.
• Strong written and verbal communication skills. Adept at creating presentations tailored to a specific audience. Able to develop technical documents including work instructions.
• Detail-oriented, organized, and self-motivated.
• Collaborative in nature and a desire to be part of a fast-paced, dynamic, cross-functional environment.
• Clinical experience developing or validating assays (IVD, LDT, and/or CDx) in a regulated environment.
• Background/expertise in Sequencing, non-invasive prenatal testing, proteomics, methylation, single cell, or oncology preferred.
• Experience with design controls, risk management, and change management preferred.
• Prior experience with study design for validations/verifications preferred.
• Hands-on experience with next-generation sequencing technologies is strongly preferred.
• Experience with automation / liquid handling robots (e.g. Tecan, Hamilton, Eppendorf) is desirable.
• Knowledge of NGS secondary analysis and data analysis software tools such as JMP or R desirable.