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Staff/ Sr.Staff Scientist - Assay On Market Support And Development at Illumina, Inc. in San Diego, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Position Summary:

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

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf