Analytical Testing Manager

5 days ago


Singapore beBeeVirologist Full time

Job Opportunity

This position plays a pivotal role in ensuring the quality and reliability of analytical testing within our laboratory. The successful candidate will be responsible for leading, coaching, and developing personnel to perform analytical testing and data review in a timely and reliable manner, adhering to Standard Operating Procedures (SOP).

Key Responsibilities:

  • Leadership and Development: Lead and coach personnel to ensure that analytical testing and data review are performed efficiently and effectively.
  • Quality Systems and Compliance: Ensure that 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).
  • Analytical Method Development: Develop, optimize, implement analytical methods, and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
  • Policy Development: Develop the organization's quality testing policy in alignment with regulatory standards.
  • Lab Method Validation: Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization, and optimization from R&D to Production.
  • New Assay Development: Lead the development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
  • Laboratory Investigations: Conduct, review, or approve laboratory investigations and ensure all follow-up actions are completed. Make decisions based on scientific and logical reasoning.
  • Data Analysis and Reporting: Compile data, generate reports, and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
  • Cross-Functional Collaboration: Align with MSAT, Quality, and Production teams on phase-appropriate analytical methods and strategies for in-process and QC release testing.
  • Training and Documentation: Train fellow colleagues on written procedures pertaining to equipment operation, test methods, and general laboratory operations. Draft and edit lab protocols, standard operating procedures, sampling plans, technical documents, and release testing records for regulatory or tech


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