Execute and monitor regular maintenance of laboratory equipment.
Draft and review operational documentation.
Ensure laboratory activities are performed in compliance with procedures and safety guidelines when handling, storing and disposing of hazardous or bio-hazardous materials.
Prepare or produce general consumables and reagents for R&D laboratory operation.
Prepare and handle biological specimens including blood, plasma, formalin-fixed paraffin-embedded samples, and extracted nucleic acids.
Execute development, verification, and validation studies for novel diagnostic NGS assays.
Process and manage samples using automated workflows and Laboratory Information Management System (LIMS).
Author detailed, accurate, and accessible records of experimental data, present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA).
Analyze and compile data for preparation of study reports and generate study reports.
Prepare and document design control documentation, CDx assay requirements, functional specifications, performance and study results, and other data in a QSR-compliant manner.
Partner collaboratively with the Quality Assurance and Regulatory teams to ensure that all procedural and submission documentation meets audit and accreditation standards.
Support the timely processing and reporting of oncology samples to internal and external collaborators.
Conduct investigations and analyses to troubleshoot and improving assay capabilities, enhance technical robustness and existing methods.
Maintain adequate stock and efficient use of supplies necessary for performing all procedures and preparation of reagents.
Maintain proper documentation including proper specimen handling, labeling, and quality control measures.
Be responsible for accurately recording work performed per GLP, including results and methodology.
Communicate with Biopharma partners and internal departments as needed to define specifics of cancer mutations and other related scientific queries.
Utilize cancer genomics expertise to investigate genomic mechanisms of oncogenesis.
Work collaboratively with internal colleagues to refine analysis algorithms and methods.
Contribute scientific expertise to broader projects within the Research and Development team.
Complete projects under guidance of senior lab employees.
Maintain laboratory cleanliness in compliance with the Hygiene Plan.
Perform inventory control aligned with 5S methodology.
Perform other duties as assigned.