Reports to: VP, Product

Location: Burlington, MA

About the Company
Delve Bio is on a mission to improve patient outcomes and lower healthcare costs by bringing cutting-edge genomic technology to infectious diseases. We are a well-funded biotech company backed by some of the most experienced operators and investors in the industry. Our co-founders are highly experienced researchers, clinicians, and entrepreneurs, including Dr. Matthew Meyerson, MD. PhD (Director of Cancer Genomics at Broad Institute and co-founder of Foundation Medicine) and Dr. Joseph DeRisi, PhD (Professor at the University of California San Francisco and President of the Chan Zuckerberg Biohub). Delve Bio launched its flagship metagenomic next generation sequencing platform Delve Detect in 2024, providing game-changing, infectious disease testing to patients across the US.

About the Role

Our team is hiring a Clinical Lab Operations Support Specialist. This hybrid position will support clinical laboratory operations, enable product success, and ensure patient satisfaction. This role will report to the VP of Product and will work cross-functionally and cross-institutionally with teams at the core of Delve Bio’s primary metagenomics next-generation sequencing (mNGS) commercial offering, including Product Development, Customer Support, Quality Assurance, and Clinical Laboratory Operations. This is a rare opportunity to significantly impact the success of a growing company at the forefront of precision medicine and metagenomics.

Responsibilities

The primary responsibilities of this role include enabling operational efficiency and performance through clinical sample management, reagent and materials coordination, and assay performance metric monitoring. This role will support off-site sample storage, transfer, and retention, as well as coordination of sample return and sample destruction with associated documentation. This role will also assist customer support with sample ordering, receiving, and reconciliation early at the start of the day, in addition to supporting day-to-day QC, troubleshooting, and facilitating cross-institutional communication. This role will assist with collating data in collaboration with Quality Assurance and Customer Support, to enable assay performance monitoring. Additionally, this role will assist with developing, drafting, and revising operating procedures in support of process improvement, sample receiving workflow, accessioning, and overall operational efficiency.

• Provide operational support of clinical LDT, serving as a point of contact for laboratory scientists in a cross-institutional capacity, including sample management, internal control material, process optimization, and operational efficiency.
• Coordinate off-site sample storage, sample de-identification, sample returns and sample destruction as needed.
• Support quality control on products, reagents, equipment, test kits, and other materials.
• Provide assistance to customer support team with sample order entry and QC
• Assist in pre-analytic and post-analytic process resolution, QC, and troubleshooting, and complete all associated documentation according to policy and standard operating procedures.
• Communicate information and instructions regarding tests and specimens to customer support, quality assurance, and the laboratory.
• Communicate significant events/information and/or pending testing to laboratory personnel, such as coordinating samples for collaboration studies.
• Participate in troubleshooting and problem-solving activities with cross-functional teams.
• Assist with evaluations and investigate in order to optimize process efficiency.
• Perform administrative tasks as needed, as well as periodic on-site attendance to enable sample transfer and management activities.
• Drive corrective action and associated documentation in consultation with Quality Assurance, Customer Support, and clinical Lab Operations as required.

Requirement 

• Bachelor’s degree required, preferably in Scientific or Technical discipline
• Minimum 3 years’ experience in a clinical laboratory or clinical-stage biotechnology company with an understanding of high-complexity clinical laboratory processing required
• Excellent knowledge of clinical production and testing environment required
• Knowledge of the processes involved in documenting laboratory procedures required
• Proficient in data capture, analysis and reporting using various IT systems
• Effective communication, both verbal and written, with customer and internal stakeholders required
• Problem solving capabilities and confidence to make clear decisions with limited information
• Must be flexible, forward-thinking, and motivated; can act independently and exercise independent judgement within boundaries of responsibility, knowledge, and skill
• Excellent time management, communication, and organization skills; ability to adjust to shifting priorities and deadlines
• Knowledge of clinical next generation sequencing preferred

Equal Employment Opportunity
Delve provides equal employment opportunities to all employees and applicants for employment without regard to race, color, national origin, religion, sexual orientation, gender, gender identity or expression, age, veteran status, disability, pregnancy or conditions related to pregnancy, or genetics.

To apply, submit resume to careers@delve.bio.