The Opportunity
Precede Biosciences is seeking a Senior Clinical Laboratory Associate to join our growing, CLIA-certified, Clinical Lab Operations group within Product Development to support scaling of our proprietary assays and Laboratory Developed Tests, focused on Next Generation Sequencing (NGS) workflows and automated liquid handling using Hamilton STAR systems. Major responsibilities of this role include routine execution of high-complexity clinical laboratory testing, ensuring compliance with CLIA/CAP/MA and other relevant regulations, supporting sample receipt and accessioning and ensuring accuracy of testing.
About Us
We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our publication in Nature Medicine.
We care deeply about creating a place where individuals can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.
What you'll bring
Qualify as a CLIA Testing Personnel for a high-complexity laboratory based upon education and relevant experience, per 42 CFR 493.1461
An associate’s, bachelor's or master's degree in chemical, biological, or medical laboratory science from an accredited institution
3+ years of hands-on industry and/or academic medical center-based experience with next-generation sequencing (NGS) and associated methodologies including DNA-seq and/or RNA-seq protocols
Minimum of two years of experience in a high-complexity CLIA laboratory including a deep understanding of CLIA regulatory requirements, quality systems, and laboratory best practices
Strong judgment in recognizing and escalating out-of-specification results, ambiguous findings, or workflow anomalies through appropriate channels, with clear and timely communication to senior staff, lab management, or cross-functional partners as required
- Familiarity with CLIA/CAP requirements, with experience supporting or participating in inspections, internal audits, or readiness activities in a high-complexity laboratory setting.
You have excellent time management and organizational capabilities necessary to deliver results in a fast-paced environment with changing and competing priorities
Demonstrated ability to work independently and collaboratively in a dynamic, fast paced team environment
Experienced user of automated liquid handlers
Prior experience working with LIMS (Laboratory Information Management System) / ELN (Electronic Laboratory Notebook)
Exposure to automation method development or script optimization (Hamilton VENUS or similar) highly preferred
Experience working with LBx (liquid biopsy) and FFPE (Formalin-Fixed Paraffin-Embedded) oncology specimens highly preferred
What you'll do
Independently perform high-complexity testing in a CLIA-certified laboratory in compliance with CLIA, CAP and internal SOPs
Execute end-to-end NGS workflows, including sample accessioning, nucleic acid extraction, quantification, library preparation, and sequencing setup
Operate and perform routine testing on automated liquid handling platforms
Identify workflow inefficiencies and propose improvements to increase throughput, robustness, and scalability
Perform and review quality control (QC) metrics; escalate and investigate out-of-specification results
Ensure accurate and compliant documentation following CLIA regulations and Good Documentation Practices (GDP)
Collaborate cross-functionally with assay development, automation and quality teams
Utilize LIMS systems to track samples, workflows, and results with strong attention to chain of custody
Participate in root cause analysis and corrective/preventive actions (CAPA) as needed
Participate in proficiency testing (PT) programs and internal alternative assessment activities in accordance with CLIA requirements; support periodic competency assessments for testing personnel.
Perform routine equipment maintenance, calibration, and function verification per manufacturer specifications and SOPs
Manage reagent and consumable inventory including lot tracking, expiration monitoring, and timely reorder to ensure uninterrupted laboratory operations
We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!
We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.
Skills Required
- CLIA Testing Personnel qualification for high-complexity laboratory
- Associate's, bachelor's or master's degree in relevant science
- 3+ years of experience with NGS methodologies
- 2+ years in a high-complexity CLIA laboratory
- Experience with automated liquid handlers
- Familiarity with LIMS/ELN
- Experience with automation method development (Hamilton VENUS preferred)
- Experience with LBx and FFPE oncology specimens
What We Do
We've experienced the significant gaps in our collective ability, as a medical and research community, to access and understand disease-defining biology when it matters most. To address this, we've developed a simple blood test to uncover actionable disease-defining transcriptional biology. Our unique genome-wide platform profiles circulating chromatin and the DNA methylome to deliver resolution into the dynamic activity of individual genes and pathways in diseased tissues from just 1mL of plasma. By partnering with developers of new medicines and advancing our own diagnostic tests, we’re working towards a world where new medicine development efforts succeed more frequently, and where anyone can receive a minimally invasive diagnosis and treatment that’s precise to the biology of their disease.
