Clinical Lab Scientist - NGS Curation and Operations Support

Clinical Lab Scientist – NGS Curation and Operations Support

Location: Greater Boston, MA

Shift: Tuesday through Saturday

Salary Range: $125,000-$150,000

Overview:

Delve Bio is on a mission to improve precision medicine with cutting-edge genomic technology. We are a well-funded early-stage biotech company backed by some of the industry's most experienced operators and investors. 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).

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.

Key Responsibilities:

The primary responsibilities of this role include enabling operational efficiency and performance through review of control and clinical sample sequencing data for report preparation prior to signout, clinical sample management, reagent and materials coordination and quality control, assay performance metric monitoring, and coordination of assay investigations and performance improvements. This role will review data in real time for quality control and patient clinical report preparation. This role will also 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 support 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, troubleshooting investigations, and implementation of assay improvements. Additionally, this role will assist with developing, drafting, and revising summary documentation and 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.
• Review batch and sample-level sequencing metrics and quality control to identify issues needing resolution and prepare clinical sample data for report signout following pre-established procedures.
• Resolve individual batch and sample quality control issues in real time based on pre-established criteria and coordinate investigations of assay performance issues.
• Review test data for public health reporting eligibility and support the administrative maintenance of reporting systems and procedures.
• Prepare case report summaries, institutional results review, investigational report summaries, and other documents and data pulls as needed.
• 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.

Qualifications:

• Bachelor's degree required, preferably in Scientific or Technical discipline
• Advanced degree (Clinical Laboratory Scientist, Masters or PhD) in biological or related discipline preferred
• Minimum 3 years' experience in a clinical laboratory or clinical-stage biotechnology company with an understanding of high-complexity clinical laboratory processing required
• Excellent working knowledge of clinical production and testing environment required
• Knowledge of clinical quality control and quality assurance activities including assay monitoring metrics and responses to issues identified
• 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
• Familiarity with next-generation sequencing wet lab procedures including sample extraction, library preparation and sequence generation
• Familiarity with next-generation sequencing data analysis and sequencing quality metrics
• Knowledge of clinical metagenomic next generation sequencing preferred

If you are a motivated self-starter with direct experience in clinical LDTs and a desire to work in a fast-paced, dynamic environment, we encourage you to apply for this exciting opportunity. Delve Bio is committed to fostering a diverse and inclusive workforce, and we welcome applications from all qualified candidates.

Full-time, remote/hybrid (Greater Boston, MA)

The salary range for this role is $125,000-$150,000. Level, title, and compensation commensurate with experience.