Reports to: VP, Product Development

Location: San Franciso (on-site)

Salary Range: $175k-$229k

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

As Director of Assay and Product Development, you will have a unique opportunity to join Delve Bio during an exciting stage of new product development. In this role, you will be responsible for participating in assay development, tech transfer, clinical operationalization, and validation of a metagenomic NGS-based laboratory developed test (LDT) under CLIA/CAP regulation.

You will collaborate with all functions and teams at the core of Delve’s primary commercial offering, including Bioinformatics, Clinical Laboratory Operations, Quality Assurance, Software Platform Engineering, and Marketing. This position will enhance cross-functional relationships, enabling communication and collaboration across all functions, to ensure that the Delve LDTs meet product requirements, quality standards, and applicable regulations.

Responsibilities

• Drive assay design, development, and optimization of metagenomic NGS-based high-throughput LDTs.
• Provide technical direction, interpretation, and analysis throughout late stages of product development. Work closely with clinical lab operations on the implementation of automation, commercialization, and quality control processes and procedures.
• Design laboratory methods and procedures to meet internal and external regulatory policies in order to ensure technical rigor and compliance with applicable quality and regulatory standards.
• Design, plan, and execute experiments and validation studies, perform in-depth data analysis, and present results and conclusions for internal and external review, including regulatory authorities.
• Define and execute development strategies aligned with the company’s scientific and commercial goals. Work closely within internal product development activities and quality objectives, as well as parallel development of software engineering and bioinformatics, to drive product development roadmaps and project prioritization.
• Follow principles of Design Control to define and plan project and product goals, design experiments and achieve them in collaboration with the product core team.
• Participate in the implementation of design and development documents, laboratory documentation, quality control procedures, and performance metrics and monitoring.

Requirements

• PhD in molecular biology, genetics, microbiology or a related discipline preferred; MS or BS may be acceptable with commensurate experience
• 10+ years of assay development experience in industry required, preferably with emphasis on NGS assays, LDTs, and/or IVDs
• Deep understanding, extensive experience, and strong technical proficiency with NGS method development required
• Extensive experience in microbial nucleic acid extraction, NGS library prep workflows, NGS sequencing platforms, and NGS data analysis
• Clinical laboratory experience required; experience with high-complexity molecular testing, including LIMS, liquid handling, and automation
• Strong knowledge and demonstrated experience in experimental design, verification / validation, statistical data analysis and data interpretation
• Strong experience with microbiology, virology and/or infectious disease assay development
• Proven experience managing and mentoring scientific teams; able to foster a culture of high performance, quality, and accuracy
• Highly collaborative and able to work efficiently in cross-matrixed multidisciplinary setting
• Ability to collaborate in a fast-paced environment with rapidly changing priorities: proactive contributor who thinks ahead, plans, and suggests solutions. Excellent project management skills, including the ability to manage multiple projects concurrently, set milestones, and deliver clear results on time
• Self-motivated with proven track record of scientific achievement as demonstrated by publication and presentation record
• Strong interpersonal and communication skills (written and verbal) with the ability to effectively communicate with cross-functional internal and external teams
• Demonstrated ability to work independently in startup environment; innovative in overcoming technical challenges with strong problem-solving ability, with impeccable attention to detail
• Experience with metagenomics is a plus

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.