Assay Development

4 hours ago

Singapore CELLVEC PTE. LTD. Full time

To lead QC release testing of viral vectors pipeline of gene therapy products. The incumbent will be responsible for implementing quality testing policies and procedures in alignment with regulatory standards in viral vector manufacturing and to ensure high quality processes and products.
- Responsible for the operational aspects of all analytical testing within the QC Laboratory.
- Lead, coach and develop QC personnel (analysts and scientists) to ensuring that analytical testing (chemical, physical and microbiological) and data review is performed in a reliable and timely manner to support production operations with adherence to Standard Operating Procedures (SOP).
- Ensure that the 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).
- Develop, optimize, implement analytical methods and working procedures for characterization, release, and stability testing of viral vector gene therapy products.
- Develop the organisation's quality testing policy in alignment with regulatory standards.
- Lead and perform lab method validation, transfers of analytical methods from other collaborators/clients, protocol harmonization and optimization from R&D to Production.
- Lead development and qualification of new and/or improved assays and characterization of viral vector products using molecular, biophysical, and other analytical assays.
- Conduct, review or approve laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning.
- Compile data, generate reports and perform computations using data analysis software, spreadsheets, graphing, and curve fitting software.
- Align with MSAT, Quality and Production teams on phase appropriate analytical methods and strategies for in-process and QC release testing.
- Collaborate with team members to identify and evaluate assay improvements with the goal of optimizing the current rAAV production process.
- 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 transfer purposes.
- Ensure real time documentation, maintain data integrity and appropriate traceability as per quality system.

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