Sr Scientist - RGH Product Development

Illumina   •  

San Francisco, CA

Industry: Biotech/Pharma

  •  

5 - 7 years

Posted 396 days ago

Tasks and Responsibilities

  • Initiate, direct and execute development activities in a fast-paced product development environment through managing a small team or individual studies
  • Take a leadership role in projects and guide technical areas independently. Make decisions involving designing, performing, troubleshooting, analyzing and reporting results for development and verification and validation studies
  • Work closely with scientific, engineering, quality, regulatory and commercial teams to develop, validate, transfer, and sustain RGH clinical products
  • Optimize existing methods, improving processes and scaling up to achieve commercial levels of stability, robustness, and performance
  • Develop and execute systems integration plans for complex work flows involving automation
  • Manage goals within defined target timeframes and make decisions regarding the goals and progress of small project teams
  • Follow internal product development procedures, as well as ISO13485 and QSR guidelines
  • Write reports and present results and project assessments to Senior Management
  • Interface with various departments and serve as internal consultant
  • Solve complex technology and development challenges
  • Perform data analysis

Required Skills & Experience

  • PhD in molecular biology, genetics, genomics or related field
  • 6-10+ years’ product development experience in commercial product development, preferably in the molecular diagnostics domain. Development of products for IVD oncology markets strongly desired
  • 5-7 years’ experience in technical leadership of PhD scientists
  • Strong background in genetics, genomics, biochemistry and enzymology and a sound understanding of genetic assay development required
  • Experience with DOE, design for manufacturing and design for robustness techniques required
  • Ability to fully integrate a system from sample extraction to report
  • Experience with next-generation sequencing
  • Experience with development for regulated markets and design controls and working knowledge of ISO13485 and QSR guidelines strongly desired
  • Experience with DNA and RNA based genomic assay development with control materials and QC metrics
  • Must be able to design experiments and perform data analysis for others and have demonstrated experience in achieving results with team members in non-biological disciplines
  • Ability to translate corporate goals into executable plans understanding technical risks, mitigations and alternatives
  • Exceptional data analysis and interpretation skills
  • Excellent communication and team management skills
  • Highly motivated, detail oriented individual with the proven ability to think innovatively toward solving problems effectively and efficiently

7615BR