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Analytical Testing Lead

3 weeks ago

Singapore beBeeQuality Full time $120,000 - $150,000
Job Title

Lead Quality Assurance Specialist.

Job Responsibilities:

Oversee the operational aspects of analytical testing in a quality control laboratory setting. Ensure reliable and timely data review supports production operations in adherence to standard operating procedures.

  • Develop, implement and optimize analytical methods for characterization, release, and stability testing of viral vector gene therapy products.
  • Lead the development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
  • Compile data, generate reports, and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
Qualifications

Candidates should hold a PhD in Cell and Molecular Biology, Immunology, Biotechnology, Biochemistry, Microbiology or related fields with 6+ years of relevant experience or Master/Bachelor's degree with 8+ years of relevant industry experience in a cGMP setup.

  • Prior experience performing viral genome titre, infectivity, potency, host cell protein, and host cell DNA assays is required.
  • Extensive hands-on experience with the development of analytical techniques for characterization and analysis of viral vectors is desired, including: Flow cytometry, qPCR, dPCR, ELISA, SDS-PAGE, Western blot, mycoplasma, sterility, endotoxins.
  • Strong knowledge of Regulatory and Pharmacopeia requirements for viral vector gene therapy products is essential.
  • A highly motivated team player with excellent organizational and collaborative skills is required.