Lab Associate Scientist

Key Responsibilities :

• 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.

Qualifications :

• Bachelor’s degree in related field and 3+ years of research experience preferred in the life sciences industry; OR,
• Master’s and 2+ research experience preferred in the life sciences industry; OR,
• Familiarity with nucleic acid handling (e.g., SPRI and PCR) and quantification techniques (e.g., Nanodrop, Bioanalyzer, Fragment Analyzer, ddPCR).
• Familiarity with NGS protocols (preferred).
• Excellent organizational, communication and interpersonal skills.
• Willingness to work collaboratively in a fast paced environment with a high level of self-motivation
16 days ago