Sr Scientist - Assay Development

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.

The Sr. Scientist role in the development and validation team of Illumina Laboratory Services will work on the development and validation of clinical diagnostic workflows and processes for research and clinical use.

The primary function of this position will be to drive development efforts of our clinical diagnostic pipeline(s) in CLIA lab. The ideal candidate will be experienced in molecular biology methods for nucleic acid applications and sequencing, will be able to lead and communicate multi-disciplinary investigations and resolution of technical problems, plan/execute experiments for use in development studies and validations and write technical documents. The candidate will interface with cross-functional teams and should be able to collaborate and represent key findings to relevant stakeholders.

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, 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 technologies from development to the CLIA laboratory.

• Collaborate and communicate with cross-functional groups and work with key stakeholders to launch new workflows and improve existing lab processes.

• Able to identify risks in study designs and provides recommendations for risk mitigation in area of responsibility and at critical interfaces to other teams.

• Support and troubleshoot existing processes and provide guidance on potential resolutions and enhancements.

• Work across a wide range of techniques, such as but not limited to sample preparation, library prep, and next-generation sequencing.

• Training and guiding supporting scientists on technical skills in one's area of expertise.

• Demonstrate advanced theoretical understanding of scientific principles within own discipline or advanced knowledge within own discipline and department, mastering most relevant areas.

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

Requirements:

• Ph.D. in Molecular Biology, Genomics, Genetics, or Biochemistry with 4+ years of experience OR MS with 8+ years of experience OR BS with 10+ years of experience in a laboratory environment performing research or development activities in an academic or industrial setting.

• Knowledge and hands-on skills working with a variety of molecular biology/nucleic acid-based techniques, assays, library prep protocols, PCR and NGS.

• Excellent skills in experimental design, implementation, troubleshooting, and data analysis.

• Demonstrated ability for technical proficiency, scientific creativity, and critical thinking.

• 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.

Preferred Requirements:

• Hands-on experience with next generation sequencing technologies strongly preferred.

• Knowledge of NGS secondary analysis and data analysis software tools such as JMP or R.

• Experience with automation / liquid handling robots (e.g. Tecan, Hamilton, Eppendorf) is desirable.

• Clinical experience developing or validating assays (IVD, LDT, and/or CDx) in a regulated environment.

• Experience with design controls, risk management, change management preferre