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Analytical Science & Technology Leader

Salary undisclosed

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Role: Analytical Science and Technology Leader

Department: Quality Control (QC)

Job Summary

As a problem solver and technical leader, lead Singapore site QC AST team to continuously improve QC data quality and operation efficiency. Responsibilities include but are not limited to:

  • Continuously evaluate and optimize analytical methods to ensure they meet their intended performance objectives.
  • Lead thorough laboratory investigations to identify root causes and implement corrective actions.
  • Lead method transfer from clients or from other XDC sites.
  • Lead method validation for PPQ projects.
  • Assess and introduce new technologies to continuously improve QC operational efficiency and data quality.

Responsibilities

  • Resource Planning, Hiring, Training and Career Development, and Talent Retention.
  • Department Strategic Planning, formulating Key Performance Indicators and Action Plans.
  • Lead the AST team in the following activities:
  • Optimize and validate P analytical methods.
  • Draft and review technical documents such as methods, qualification/validation protocols and reports.
  • Serve as the technical leader to solve technical challenges and lead laboratory investigations.
  • Communicate with internal/external partners or clients to ensure timely completion of method validation and smooth transfer of analytical methods.
  • Conduct statistical analysis based on historical data to assess method performance or to support laboratory investigations.
  • Introduce new technology and improve QC testing capabilities.

Qualifications

  • Bachelor’s degree or higher in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, Statistics or a related field.
  • 8+ years of experience in the biopharmaceutical industry for a Master’s or PhD, and a minimum 10 years for a Bachelor’s degree.
  • Strong communication skills in English and Chinese (as this role requires frequent internal collaboration with Chinese-speaking colleagues in HQ) , fluent in speaking, writing and reading in both languages.
  • Proficiency in statistical analysis and technical writing in English.
  • Strong logical and critical thinking, scientific reasoning, and problem-solving abilities.
  • Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur. P, ChP pharmacopeias.
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