Senior Clinical Laboratory Associate

Precede•Boston, MA

7d•$80,000 - $90,000

About The Position

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.

Requirements

Qualify as a CLIA Testing Personnel for a high-complexity laboratory based upon education and relevant experience, per 42 CFR 493.1461
An associateâs, 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
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)

Nice To Haves

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

Responsibilities

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