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Associate Director Product Development

Craif Inc.
Irvine, CA Full Time
POSTED ON 1/13/2025
AVAILABLE BEFORE 4/9/2025

Craif is a biotech startup with a commercially profitable diagnostics business in Japan. The company is expanding its operations to the US.

The company is seeking a dedicated and innovative Associate Director of NGS-Based Product Development to join the US team and lead the development of a urinary miRNA and cell free DNA assays. The ideal candidate will possess 5 years of direct expertise in both wet and dry NGS processes, with an ability to drive assay improvements based on data-driven insights. Key responsibilities include designing sophisticated assays in the NGS lab environment, calibrating, enhancing, and validating assay protocols, and conducting data analysis. This role requires an entrepreneurial mindset, as you will play a critical role in establishing and building out the US labs. This is a full-time onsite position working in a lab located in Southern California, near Irvine, CA..This position reports to…..

Key Responsibilities :

  • Design and execute miRNA and cell free DNA assays from urine samples, including DNA / RNA purifications, library constructions, and NGS runs.
  • Play a pivotal role in establishing a new lab space, setting up equipment, and developing workflows to support the assays and further R&D initiatives.
  • Coordinate raw NGS data analysis, report results and plan the next steps.
  • Collaborate closely with teams in Japan to ensure smooth assay transfer, knowledge exchange, and continuous improvement.
  • Participate in discussion to improve assay quality and reproducibility

Qualifications

  • PhD in molecular biology, genetics, or a related field with 5 years of experience in both NGS assay development as well as data analysis / interpretation.
  • 3 years of experience in the commercial molecular diagnostics or biotech sector within a FDA regulated environment.
  • Proficiency in NGS data analysis with 3 years of hands-on experience using R, Python, or similar programming languages.
  • Experience with statistical design of experiments supporting robust assay design.
  • Demonstrated communication and collaboration skills to work effectively with colleagues in Japan, ensuring the development of a reliable, reproducible, and robust assay.
  • Pioneering mindset with a strong motivation to drive the development of a cancer-diagnostic assay
  • Adaptability, patience, and flexibility to navigate and respond to rapid changes in a fast paced start-up environment.
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