Director, Laboratory Process Development and Integration, Sequencing

Organization
Roche Sequencing Solutions, Inc.
Job Location
5945 Optical Ct
San Jose, CA 95138
Salary
doe
Job Description

 

Responsibilities:

  • Improve laboratory operations and data quality by driving metric review and analysis improvements. Identifying and resolving process bottlenecks, weaknesses and failures.
  • Participate and lead team investigations of quality issues
  • Lead continual assessment of quality indicators through trend monitoring and additional analytical efforts.
  • Technical education of laboratory staff
  • Coordinate implementation of laboratory process and chemistry changes
  • Interface with bioinformatics and laboratory automation groups to refine and develop quality monitoring and metrics
  • Liaise with research and development groups to facilitate the adoption key process changes.
  • Liaise with bioinformatics, research and development groups to communicate issues with processes, changes to process and translate findings into actionable improvements in clinical lab.
  • Improve and develop laboratory LIMS tools and methods to improve results reporting, tracking of laboratory issues and data presentation.
  • Participate on teams assembled to develop adoption of new diagnostic tests
    • Quality metric review and definition
    • Reporting and metric review processes
    • LIMS development and testing
    • Production simulation and data analysis
    • Identification of equipment and laboratory needs
    • Documentation and training of new test methods as indicated by regulatory requirements
Requirements

 

  • PhD level scientist or manager
  • 7-10 years of experience in laboratory and project management of a high complexity high throughput molecular biology lab
  • Experience in a service lab environment – NGS Sequencing, Genotyping, Array
  • Proven experience in analyzing and managing large data sets
  • Experience in automation development and management, in particular liquid handling
  • Experience in assay and process development of standard molecular biology techniques
  • Extensive experience in process troubleshooting of a high complexity, high throughput genetics or molecular biology lab,
  • Familiarity with ISO13485 and CLIA regulations
  • experience working in a CLIA or ISO regulated environment
  • Technology transfer experience.
  • Basic to advanced competency in statistical analysis
  • Knowledge of fundamental Human Genetics
  • Experience in personnel management
  • Experience in project management
About Our Organization

Who we are

At Roche, 91,700 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. 

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point

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