Laboratory Systems Scientist

Natera•Boulder, CO

4d•$103,000 - $115,000•Onsite

About The Position

The Laboratory Systems Scientist at Foresight Diagnostics will be responsible for supporting laboratory operations infrastructure as a technical SME. The Laboratory Systems Scientist will collaborate with research, development, clinical, bioinformatics, software, operations, regulatory, quality, to enable laboratory system development, implementation and maintenance. This is a full-time position based in Colorado working standard business hours in a startup company, that will require the flexibility to work diverse schedules, including evenings, weekends, and holidays for critical deliverables. This position will report to the Senior Manager, Operational Excellence & Process Engineering.

Requirements

4+ years of experience of relevant laboratory work experience or 2+ years with MS or PhD.
2+ years of experience in CAP, CLIA, NYSDOH, ISO 13485/15189 environments.
Bachelor’s or Master’s degree in chemical, physical, biological, or clinical laboratory scientist or medical technology from an accredited institution.
Experience performing complex molecular biology workflows, ideally NGS workflows.
Previous experience designing and performing validations and verifications, process development and process-directed documentation.
Experience with agile-scrum methodology and collaboration with laboratory, software and bioinformatics teams.
Experience with laboratory batch records, LIMS, FreezerPro, and other laboratory software solutions.
Experience in complex problem solving and risk management/mitigation (i.e. identify potential equipment, automation or chemistry failures).
Analytical and operational skills with an ability to identify meaningful insights from complex data.
Energy, motivation, and flexibility with excellent oral and written communication.
Ability to manage multiple projects and tasks concurrently with strong attention to timeline and performance metrics.
Demonstrated ability to work in a dynamic fast-paced environment, establish, and meet deadlines.
Ability to think critically to overcome hurdles and devise solutions.

Responsibilities

Operate as a technical SME and stakeholder dedicated to development, implementation, and release testing for laboratory non-product software and automation solutions.
Collaborate with the Program Management and laboratory leadership to extract, capture, and refine user needs and requirements for software and automation solutions.
Under the guidance of the Senior Manager and Laboratory Director, develop PQ, validation, and verification plans and execute to protect and scale Foresight’s laboratory operations without impact to capacity and clinical testing in alignment with CAP, CLIA, NYSDOH and other regulations.
Interpret and present data and results of all analysis according to set procedures and guidelines and draft reports for PQ, validation and/or verification activities.
Identify and resolve problems that may adversely affect equipment, automation, or test performance.
Partner with Automation Engineering to support automation development, process improvements, and knowledge tech transfer to facilitate comprehensive PQ, validation and/or verification plans for automation implementation or return to service.
Identify operational process improvements and efficiencies, present to operations leadership quality and efficiency solutions, and collaborate cross functionally to execute on approved solutions to protect and scale laboratory operations.
Develop and implement internal equipment management and maintenance programs to ensure high performance of equipment and instrumentation within Foresight’s laboratory supporting research, regulated, and clinical testing.
Partner with Automation Engineering to develop and implement routine maintenance programs for the automated platforms.
Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful implementation of laboratory systems into the laboratory testing workflow.
Support in the creation of training materials.
Maintain proficiency in wet lab processes to operate on the bench when lab staffing, capacity, training, and sample criticality require.