Senior Scientist

Job Responsibilities

• Plan, execute, analyze, and document IVD product development activities with superb attention to detail under a design control system.
• Development and optimisation of liquid biopsy-based cancer screening tests. Process to develop include blood/body fluid collection, nucleic acid extraction, NGS library preparation, bioinformatic analysis, data interpretation and machine learning model building
• Major goal is to preserve and capture cancer signal from liquid biopsy sample, and precise determination of cancer patients.
• Ensure product performance by employing proven development practices – optimization, guardband testing, gauge R&R, stability testing, LOQ testing, and so forth, following regulatory recommended guidelines.
• Make fundamental scientific contributions toward producing robust products.
• Develop and implement quality control procedures for critical reagents and processes.
• Perform data analysis with advanced analytical and statistical tools (JMP, Excel).
• Keep a detailed laboratory work tracking and summarize work in research reports and laboratory meeting presentations.

Job Requirements

• PhD with 2 years of prior experience in a diagnostic product development role.
• Track record of developing diagnostic tests or reagent kits in a regulated environment; knowledge of design control process is advantageous.
• Experience assembling IVD documentation such as Design History Files is advantageous.
• Mastery of NGS-based assay development. Hands on experience with NGS on Illumina platforms.
• Mastery of multi-omic assays, master mix formulation, protocol optimization; fundamental expertise in nucleic acid quantitation and fragment analysis.
• Experience in cancer screening and cell free DNA technologies.
• Very strong analytical and problem-solving skills; organized and efficient.
• Proven interpersonal, communication, and presentation skills; excellent time management skills.
• Superb attention to detail; produces work of exceptional quality and accuracy.
• Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities.
• Ability to proactively identify issues and address with solutions-oriented approach.