As a Staff Scientist or Senior Staff Scientist within Illumina’s Assay Development organization, you will drive support of on-market products through the application of diverse scientific principles. You will be a technical expert within a multi-disciplinary team working to ensure Illumina products meet their stated claims, global regulatory requirements, customer expectations, and remain competitive in the markets they serve. You will help to conceptualize, troubleshoot, and optimize assays and processes to maintain and expand Illumina’s market share in current and new markets.
Tasks and Responsibilities
As part of the Assay On-Market Support and Development team, plan and coordinate technical and cross-functional activities to drive design changes, troubleshooting projects and investigations.
Take a leadership role on projects and guide technical areas independently both within and adjacent to area of technical expertise. Initiate, direct, and execute development activities through the management of a team to achieve project goals and deliverables
Effectively make decisions in area of responsibility and communicate rationale and tradeoffs considered to a cross functional team
Successfully work cross functionally with and / or lead Scientists, RA’s, Engineers, Bioinformaticians, SW, quality, manufacturing and commercial personnel to optimize assay conditions and manufacturing / QC processes to achieve commercial levels of stability, robustness, and performance
Troubleshoot issues and suggest creative solutions to system-level challenges.
Work across a wide range of technologies, including sample extraction, library prep, and next-generation sequencing
Lead risk analysis and FMEA activities for project team
Partner with Marketing, Regulatory, and other stakeholders to support communications to the field and to our customers
Be a strong technical mentor for junior team members
Required Skills & Experience
Ph.D. in Genomics, Genetics, Molecular Biology or Biochemistry with 7+ years’ experience in biological assay development in an academic or industrial setting; or equivalent work & educational experience
Experience in a successful product development environment required. Clinical product development experience strongly preferred.
Participation in the product development, verification and validation, regulatory submission, and successful launch of a clinical diagnostic device for regulated markets; demonstrated knowledge of design controls and risk management
Experience with transfer of new products to manufacturing and/or QC preferred
Demonstrated ability to understand and successfully work across multiple disciplines such as engineering, software and manufacturing
Excellent verbal/written communication and interpersonal skills.
Experience in molecular biology methods for nucleic acid analysis and manipulation including purification, amplification, labeling, hybridization, etc.
Excellent skills in experimental design, implementation, troubleshooting, and data analysis.
Demonstrated ability to learn new scientific and technological approaches
Analytical, detail-oriented, organized, takes initiative, and self-motivated
Strong organizational and time-management skills including managing projects simultaneously.
Experience with change management, CAPA and failure investigation desirable.
Must have a desire to be part of a fast-paced, dynamic, cross-functional environment
Experience in using data and risk driven approach to influence technical decisions at a project level; objective evaluation of implications and consequences of the technical approach
1-3 years’ experience in a functional management role
Preferred Skills & Experience
Hands-on experience with next generation sequencing technologies (NGS). Experience with HiSeq, NextSeq or MiSeq operation is desirable
Experience with Illumina’s sample prep methods strongly preferred
Experience with liquid handling robots (e.g. Tecan, Hamilton, Eppendorf) is desirable
Knowledge of NGS secondary analysis techniques, and data analysis software tools such as JMP or R desirable
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