About the Job

The Manager of Laboratory R&D Automation Development will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.

The Manager, Automation Development is responsible for leading a team of Automation Engineers that develop new automation solutions to support FMI’s Research and Development teams.  The selected individual should have extensive experience developing and deploying novel automated laboratory solutions for Next Generation Sequencing (NGS) as well as overseeing a team responsible for the automated systems deployed in the research lab. The incumbent has a strong acumen for program management and process improvement, in order to drive strategic initiatives that ensure that our diagnostic tests continually deliver the highest quality results to our patients. 

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

Key Responsibilities

• Lead a team of Automation Engineers in Cambridge, MA and San Diego, CA; focused on the development of automated solutions for NGS-based and other Diagnostic Assays.
• Work collaboratively with bench scientists to build and optimize innovative automation methods and assays.
• Ensure the Automation staff conducts development activities for automation systems per our Product Development and Quality Processes, including documentation associated with requirements gathering, development, IQ, OQ, Test Method Validation.
• Collaborate and partner with FMI’s internal and external stakeholders to deliver new solutions. Development of these new solutions is in collaboration with Research and Development and is aligned with Technology Operations and our automated clinical laboratory processes.
• Assist Product Development Leadership Team in planning and budgeting capital equipment, and staffing organization as required to implement our department strategy.
• Review and critique presentations for others and present complex technical data to large and diverse groups.
• Lead and participate in cross-functional project teams to support key business objectives.
• Establish New Equipment Specifications:
  • Use technical knowledge and expertise to support the design, maintenance, scale-up, optimization, automation, troubleshooting and validation of laboratory processes or equipment.
• Advance success of the organization by championing functional capabilities and perspectives, while holding an enterprise and growth mindset.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in the Life Sciences, Bioengineering or Biotechnology.
• 5+ years of experience development of Laboratory Automation for biochemical assays.
• 2+ years of experience in a leadership role.

Preferred Qualifications

• Master’s Degree in the Life Sciences, Bioengineering or Biotechnology
• 10+ years’ experience development of Laboratory Automation for NGS assays
• 3+ years’ experience in a leadership role including direct management of team members
• Experience:
• implementing automated solutions in satellite labs
• in a translational research or molecular diagnostics lab
• working in a CLIA, CAP, QSR, or regulated laboratory setting
• working with Automation in a laboratory with electronic data capture (in place of paper logs and notebooks)
• with operating and programming liquid handling robotics platforms (especially from Hamilton, TECAN, Agilent Technologies, or Beckman Coulter)
• developing and supporting methods on Hamilton, Beckman, Agilent liquid handlers and Illumina sequencing systems
• Understanding of laboratory management practices, process improvement, customer orientation, and information technology
• Experience with standard molecular biology techniques such as nucleic acid isolation, purification and quantitation, bioanalyzer, DNA/RNA quantitation, qPCR or Next Generation Sequencing
• Experience developing and implementing integrated robotic systems for use in a high throughput environment
• Experience communicating and collaborating with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines
• Strong focus on quality, laboratory automation/ liquid handling, new technology, mentoring personnel, and possessing of strong general leadership skills
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion

On-site Essential