CLIA Laboratory General Supervisor

Precede•Boston, MA

1d•$150,000 - $220,000

About The Position

Precede Biosciences is seeking a CLIA Laboratory General Supervisor (open to Manager/Senior Manager/Associate Director-level) to join our growing, CLIA-certified, Clinical Lab Operations group within Product Development to support optimizing and scaling of our proprietary assays and Laboratory Developed Tests. Major responsibilities of this role include supervising a high-complexity clinical laboratory, ensuring compliance with CLIA/CAP/MA and other relevant regulations, supporting sample receipt and accessioning, ensuring accuracy of testing, collaborating with QA and maintaining staff competency. In addition, youâll oversee hiring and supervision of testing personnel, review QC and results, implement proficiency testing, maintain documentation, support inspections, and facilitate training. 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. Who will love this job You love being âhands-onâ in the lab, mastering complex automated sample processing workflows on the cutting edge of molecular biology. You have experience building and scaling lab processes and teams in compliance with CLIA and other regulations, while ensuring delivery of high-quality results. You are known for your exceptional attention to detail, ensuring lab operations are consistent and reliable.

Requirements

Qualify as a CLIA General Supervisor 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
At least 5+ 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 four years of supervisory or managerial experience in a high-complexity CLIA laboratory including a deep understanding of CLIA regulatory requirements, quality systems, and laboratory best practices
Must possess or be able to obtain the MB(ASCP) or equivalent within the initial 180-day introductory period
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, or programmer, of automated liquid handlers
Prior experience working with, or developing, LIMS (Laboratory Information Management System) / ELN (Electronic Laboratory Notebook)

Nice To Haves

Experience working with, or supporting development of clinical laboratory testing for FDA submission and consideration
Experience working with LBx (liquid biopsy) and FFPE (Formalin-Fixed Paraffin-Embedded) oncology specimens

Responsibilities

Provide day-to-day supervision of high-complexity testing by qualified testing personnel and ensure regulatory compliance, staff competency, continuing education and training are maintained
Youâll be a part of a growing, cross-functional team responsible for scaling our regulated lab, ensuring delivery of new clinical insights to physicians and their patients
Build and lead a team of clinical lab technologists to support routine sample processing from sample receipt through result generation and reporting
Process clinical samples for internal and external stakeholders
Monitor QC metrics and communicate results to cross functional teams
Collaborate with Quality Assurance, ensuring lab is compliant with relevant regulations and patient results are reported in compliance with relevant policies and procedures
Support implementation of process improvements including LIMS and automated lab methods
Be accessible to testing personnel during clinical lab working hours to provide technical support
Serve as a delegate of the Laboratory Director over the day-to-day laboratory activities