Analytical Lead Specialist

3 days ago

Singapore beBeeAnalytical Full time $180,000 - $200,000
Senior Analytical Specialist

Job Overview:

The Senior Analytical Specialist will be responsible for leading the analytical testing team to ensure reliable and timely delivery of results to support production operations. They will develop, optimize, and implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.

Responsibilities:

  • Lead and coach analytical personnel to perform testing in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
  • Develop, optimize, and implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
  • Ensure quality systems and practices in the laboratory comply with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP) and Quality Management Standards (QMS).
  • Collaborate with cross-functional teams to align analytical methods and strategies for in-process and QC release testing.
  • Conduct, review or approve laboratory investigations and ensure all follow up actions are completed.
  • Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
  • Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operations.

Qualifications:

  • 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 a minimum of 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 are required.
  • Extensive hands-on experience with 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.
  • Experience in the design and optimization of cell-based potency and infectivity assays.
  • Must have experience facing regulatory, Client & external cGMP audits.
  • A highly motivated team player with an ability to be productive and a willingness to lead and learn in a fluid, fast-paced environment.
  • Excellent organizational and collaborative skills.

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