Laboratory Systems Scientist
PharmaBiotechMedTechRegulatory AffairsQuality Assuranceemaiso 13485croinformaws
Job description
Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)
Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer. We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us. Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.
About The Role
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.
What You Will Do 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. What You Will Bring 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. Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: Annual performance incentive bonus
Long-term equity awards
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits Compensation Range
$103,000 - $115,000OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories,
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