Octave Clinical Laboratory Scientist

About the Company

Octave Bioscience is developing a suite of novel measurement tools that feed into structured analytical data models designed to improve care management decisions to ultimately create better patient outcomes at lower costs. We are currently focused on neurodegenerative disease, starting with multiple sclerosis (MS), to bring direct and positive impact to people’s lives. Our CLIA Certified, CAP Accredited Laboratory has developed a hybrid immunoassay-qPCR test as a Laboratory Developed Test.

About the Role

The Clinical Laboratory Scientist (CLS) will be responsible for performing high-complexity laboratory testing on patient specimens; conducting quality control and quality assurance procedures; performing data analysis and interpretation of complex data, and reporting results. All activities must comply with applicable local, state, and federal laboratory regulations. This role requires accurate manual pipetting, meticulous and organized recordkeeping, excellent attention to detail, strong written and verbal communication skills, and the ability to multitask, adapt to changing schedules, and work both independently and collaboratively to deliver high-quality results efficiently.

Shift Hours: Tue – Sat AM

Responsibilities

• Perform moderate and high complexity laboratory tests according to approved policies and procedures for all phases of testing; pre-analytic, analytic, and post-analytical.
• Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.
• Maintain records that demonstrate proficiency testing samples are successfully tested in the same manner as patient specimens.
• Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.
• Being proactive in identifying issues that may adversely affect test performance or reporting of test results and working directly with the general supervisor, technical supervisor, clinical consultant, or director to troubleshoot and implement process improvements.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
• Participating in instrument validations, proficiency testing and quality assurance activities.
• Develop and/or revise laboratory documents including policies, procedures, and forms.
• Participate in cross-functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the Octave Clinical Laboratory, including compliance with all applicable standards and regulations.
• Assisting the technical supervisor in method-verification studies and validation of laboratory-developed tests or any additional task as assigned.
• Participating in the monitoring of the inventory of clinical laboratory supplies and materials.
• Providing direct and constant supervision of laboratory assistants.
• Comply with all local, state, and federal laws and regulations governing clinical laboratory operations including maintaining confidentiality of personal health information (PHI).

Qualifications

• Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science, or related field.
• A current California Clinical Laboratory Scientist License that meets requirements for Testing Personnel under CLIA regulations (42 CFR, part 493) - Generalist license is required.
• 2+ years’ experience in a clinical laboratory setting; experience in start-up environment and in a high complexity molecular testing environment preferred.
• Experience in immunoassay and PCR techniques.
• The ability to accurately pipette in plate-based assays.
• Flexibility of work schedule to meet the needs of Octave’s Clinical Laboratory.

Required Skills

• Demonstrated proficiency in computer skills, such as Google Workspace, Microsoft Office Suite (Word, Excel), basic statistics, and laboratory information systems (LIMS).
• Strong verbal and written communication skills.
• In-depth understanding of Good Laboratory Practices (GLP), CLIA/CAP/NY State regulations, and quality standards.
• Strong data analysis skills with the ability to interpret visual data representations (color graphs) and draw conclusions from vast amounts of data.
• Highly detail oriented with strong analytical thinking and the ability to exercise independent judgment in a fast-paced laboratory environment.

Physical Demands, and Work Environment

• Standing or sitting for long periods of time may be necessary.
• Some lifting (greater than 25 pounds) may be necessary.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Repetitive manual pipetting may be necessary.