Clinical Laboratory Scientist at J Craig Venter Institute

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Molecular Testing, DNA Extraction, Next-Generation Sequencing, Automated Liquid Handling, Sample Management, Assay Validation, Regulatory Compliance, Molecular Biology, Sequencing Expertise, Training, Inspection Readiness, Quality Records, Collaboration, Troubleshooting, Data Integrity, Time Management

Industry

Biotechnology Research

Description

Position Summary The Clinical Laboratory Scientist (CLS), preferably California-licensed in Clinical Genetic Molecular Biology Science (CGMBS), will play a key role in establishing and operating a next-generation sequencing (NGS) laboratory specializing in long-read sequencing using the PacBio ecosystem. This position requires a balance of technical expertise, regulatory compliance, and adaptability to the fast-paced, dynamic environment of a startup. The successful candidate will bring hands-on experience in both clinical molecular diagnostics and research assay development, contributing to the laboratory’s growth from initial assay design through clinical launch and ongoing production. Essential Functions * Perform clinical molecular testing using a variety of techniques including DNA extraction, quantitation, library preparation, and next-generation sequencing. * Handle biospecimens in a regulated molecular diagnostic environment, ensuring compliance with CLIA, CAP, ISO, and company quality standards. * Operate and maintain automated liquid handling systems (e.g., EpMotion) to process large sample cohorts. * Support end-to-end sample management including accessioning, processing, tracking, and storage. * Perform and document routine preventive maintenance and assist with troubleshooting and corrective actions when test systems fail or deviate from specifications. * Participate in reagent qualification, inventory management, and assay validation activities. * Contribute to the drafting and revision of laboratory SOPs, validation documents, and quality records to support CLIA/CAP compliance. * Collaborate closely with R&D and bioinformatics teams to transition assays from research development into regulated clinical production. * Apply molecular biology and sequencing expertise to optimize workflows, improve assay robustness, and maintain data quality. * Assist with training of new personnel including technicians, contractors, and interns. * Participate in inspection readiness, internal audits, and continuous improvement initiatives. Pre-Requisites * Required: 1. California CLS license or California Clinical Genetic Molecular Biologist Scientist (CGMBS) license (CGMBS strongly preferred). * Education: 1. Bachelor’s degree in Molecular Biology, Biochemistry, Genetics, Chemistry, or a closely related field. * Experience: 1. Minimum 5 years of combined experience in molecular diagnostics or genomics research, including at least 2 years performing NGS library preparation and sequencing. 2. Hands-on experience with PacBio sequencing platforms and associated workflows. 3. Proven ability to perform nucleic acid extraction, sample QC, and troubleshooting of complex workflows. 4. Experience with automated liquid handlers (e.g., EpMotion) and familiarity with high-throughput environments. 5. Familiarity with LIMS and electronic data tracking tools. 6. Demonstrated success working in both regulated and research environments, including CLIA, CAP, or ISO-accredited settings. * Thrives in a startup environment where priorities evolve and flexibility is essential. * Able to think creatively and problem-solve while maintaining compliance with regulatory and quality requirements. * Strong attention to detail, meticulous documentation habits, and a commitment to data integrity. * Excellent time management, organizational, and communication skills. * Collaborative mindset with the ability to work cross-functionally with R&D, bioinformatics, and operations teams. Work Environment The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Moderate noise (i.e. wet lab with equipment, bench machines and computers). * Ability to work in a confined area. * Ability to sit at a computer terminal for an extended period of time. * Ability to stand and/or sit for an extended period of time while working in the lab. Physical Demands The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment. * Specific vision abilities required by this job include close vision requirements due to computer and lab work. * Light to moderate lifting is required. J. Craig Venter Institute is an Equal Opportunity Employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status.

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Responsibilities

The Clinical Laboratory Scientist will perform clinical molecular testing and ensure compliance with regulatory standards in a next-generation sequencing laboratory. They will also collaborate with R&D and bioinformatics teams to transition assays from research to clinical production.