Senior Lab Systems Scientist

Location: On-Site in Boulder, CO

About The Role

The Senior Laboratory Systems Scientist at Foresight Diagnostics is a critical senior individual contributor within our Operational Excellence and Process Engineering team and is responsible for leading the architecture, development, and continuous improvement of laboratory systems that enable scalable clinical testing operations. This role serves as a scientific and technical leader responsible for designing, implementing, and optimizing laboratory technologies leveraging advanced scientific and operational judgement to translate complex operational needs into robust, scalable laboratory systems that meet regulatory, safety and business requirements. 

The Senior Laboratory Systems Scientist will collaborate with R&D, Software, Bioinformatics, Laboratory Operations, Automation Engineering, and RA/QA to lead cross-functional initiatives including technology transfer, system development, validation strategy, and operational process optimization. This is a full-time position based in Colorado working standard business hours; however, the role will require flexibility to work diverse schedules, including evenings and weekends, and holidays for critical deliverables. This position will report directly to the Senior Manager, Operational Excellence and Process Engineering. 

What you will do

• Independently assess assay and operational processes to identify gaps and risk signals through the interpretation of complex performance and analytical data and operator feedback.
• Through proper problem definition and cross-functional stakeholder alignment, build business cases to present to senior leadership detailing scope, requirements, timeline, resourcing, and a project plan.
• Design, develop, and implement and/or tech transfer programs and robust, scalable processes that enable laboratory operations to meet regulatory, safety and business requirements. 
• Under the guidance of the Laboratory Director and Senior Director, Laboratory Operations develop performance qualification, 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. 
• Collaborate with Software (internal and external vendors) and Automation Engineering to build user requirements and test cases, and support release testing for laboratory non-product software and automation solutions.   
• Guide development of user requirements, test strategies, and release validation activities for laboratory non-product software and automation systems.
• Collaborate with Automation Engineering, Bioinformatics, Supply Chain, Quality Assurance, Regulatory Assurance, and Laboratory Operations to define system requirements, functional specifications, and user needs for laboratory system solutions.
• Create development protocols, study designs, execute complex wet laboratory testing, data review and interpretation, draft reports for performance qualification, validation, and verification activities, and present findings to the Laboratory Director, R&D, RA/QA, and Laboratory Operations leadership to support change management. 
• Drive operational rollout of new programs, products, and processes supporting tech transfer, training, performance monitoring and issue management through post-launch hypercare. 
• Evaluate operational outcomes through KPI data generation and monitoring, effectiveness assessments, lessons learned, and take action to develop and implement continuous improvement initiatives. 
• Serve as a senior subject matter expert for laboratory systems including wet lab workflows, automation platforms, and laboratory software solutions.
• Translate complex operational needs into robust technical system designs that enable reliable, high-throughput clinical testing.
• Partner with Automation Engineering to support automation development, maintenance programs, 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. 
• Author and oversee execution of complex validation protocols, study designs, and qualification plans aligned with CAP, CLIA, NYSDOH, ISO 13485 and other regulatory requirements.
• Author standard operating procedures (SOPs), process maps, decision trees, and/or training program materials to facilitate successful tech transfer and implementation of laboratory systems into the laboratory testing workflow. 
• As applicable, maintain proficiency in wet lab processes to operate on the bench when lab staffing, capacity, training, and sample criticality require.

What you will bring

• Advanced degree in molecular biology, engineering or related discipline. PhD or ASCP/CGMBS preferred, with equivalent industry experience considered. 
• 8+ years of laboratory experience to include R&D protocol and study designs, clinical laboratory LDT assay and automation development, and high complexity laboratory testing. 
• Lean Six Sigma Green belt certification preferred
• Demonstrated experience leading technology transfer, laboratory system development, or process engineering initiatives.
• Experience designing and executing validation, verification, and performance qualification studies in regulated laboratory environments.
• Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology. 
• Proven track record of successful program and process development to include tech transfer and training.
• Strong understanding of complex molecular biology workflows, quality and regulatory standards (ISO13485/15189, CAP, CLIA, NYSDOH). 
• Experience authoring study, validation, and/or verification plans, protocols, and reports.
• Proficiency in experimental design, data analysis, and technical problem solving.  
• Experience with agile-scrum methodology and project management for laboratory, software, and bioinformatics teams. 
• 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.
• Collaborative, adaptable, and focused on achieving business and corporate objectives.