The opportunity
Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)
What you'll 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.
What they're looking for
- 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.
