Delve Bio
Director of Assay and Product Development, Metagenomics
Delve Bio, San Francisco, California, United States, 94199
Director of Assay and Product Development, Metagenomics
Role :
Director of Assay and Product Development, Metagenomics Reports to :
VP, Product Development 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 with experienced operators and investors. Delve Bio launched its flagship metagenomic next generation sequencing platform Delve Detect in 2024, providing infectious disease testing to patients across the US. About the Role As Director of Assay and Product Development, you will join Delve Bio during an exciting stage of new product development. You will be responsible for 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 Bioinformatics, Clinical Laboratory Operations, Quality Assurance, Software Platform Engineering, and Marketing. This role will be located on-site in an incubator laboratory in San Francisco, enabling collaboration with the R&D team while maintaining virtual collaboration with the remainder of the company across the US. The position will enhance cross-functional relationships to ensure 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 automation, commercialization, and quality control processes. Design laboratory methods and procedures to meet internal and external regulatory policies to ensure technical rigor and compliance with quality and regulatory standards. Design, plan, and execute experiments and validation studies, perform data analysis, and present results for internal and external review, including regulatory authorities. Define and execute development strategies aligned with scientific and commercial goals; coordinate with software engineering and bioinformatics to drive product roadmaps and project prioritization. Follow Design Control principles to define and plan project goals, and collaborate with the product core team. Participate in the implementation of design and development documents, laboratory documentation, quality control procedures, and performance metrics. 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 and strong technical proficiency with NGS method development Extensive experience in microbial nucleic acid extraction, NGS library prep workflows, NGS sequencing platforms, and NGS data analysis Clinical laboratory experience required, including high-complexity molecular testing, LIMS, liquid handling, and automation Strong knowledge in experimental design, verification/validation, statistical data analysis, and data interpretation Experience in microbiology, virology and/or infectious disease assay development Proven experience managing and mentoring scientific teams; fostering a culture of high performance, quality, and accuracy Highly collaborative and able to work efficiently in a cross-matrixed multidisciplinary setting Ability to adapt in a fast-paced environment with changing priorities; proactive, with excellent project management and ability to manage multiple projects Self-motivated with a track record of scientific achievement (publications and presentations) Strong interpersonal and communication skills (written and verbal) with cross-functional teams Ability to work independently in a startup environment with strong problem-solving skills and attention to detail Experience with metagenomics is a plus Equal 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 related conditions, or genetics. Seniority level Director Employment type Full-time Job function Science
#J-18808-Ljbffr
Director of Assay and Product Development, Metagenomics Reports to :
VP, Product Development 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 with experienced operators and investors. Delve Bio launched its flagship metagenomic next generation sequencing platform Delve Detect in 2024, providing infectious disease testing to patients across the US. About the Role As Director of Assay and Product Development, you will join Delve Bio during an exciting stage of new product development. You will be responsible for 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 Bioinformatics, Clinical Laboratory Operations, Quality Assurance, Software Platform Engineering, and Marketing. This role will be located on-site in an incubator laboratory in San Francisco, enabling collaboration with the R&D team while maintaining virtual collaboration with the remainder of the company across the US. The position will enhance cross-functional relationships to ensure 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 automation, commercialization, and quality control processes. Design laboratory methods and procedures to meet internal and external regulatory policies to ensure technical rigor and compliance with quality and regulatory standards. Design, plan, and execute experiments and validation studies, perform data analysis, and present results for internal and external review, including regulatory authorities. Define and execute development strategies aligned with scientific and commercial goals; coordinate with software engineering and bioinformatics to drive product roadmaps and project prioritization. Follow Design Control principles to define and plan project goals, and collaborate with the product core team. Participate in the implementation of design and development documents, laboratory documentation, quality control procedures, and performance metrics. 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 and strong technical proficiency with NGS method development Extensive experience in microbial nucleic acid extraction, NGS library prep workflows, NGS sequencing platforms, and NGS data analysis Clinical laboratory experience required, including high-complexity molecular testing, LIMS, liquid handling, and automation Strong knowledge in experimental design, verification/validation, statistical data analysis, and data interpretation Experience in microbiology, virology and/or infectious disease assay development Proven experience managing and mentoring scientific teams; fostering a culture of high performance, quality, and accuracy Highly collaborative and able to work efficiently in a cross-matrixed multidisciplinary setting Ability to adapt in a fast-paced environment with changing priorities; proactive, with excellent project management and ability to manage multiple projects Self-motivated with a track record of scientific achievement (publications and presentations) Strong interpersonal and communication skills (written and verbal) with cross-functional teams Ability to work independently in a startup environment with strong problem-solving skills and attention to detail Experience with metagenomics is a plus Equal 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 related conditions, or genetics. Seniority level Director Employment type Full-time Job function Science
#J-18808-Ljbffr