My client is a world leader in the healthcare industry and are going through a period of rapid expansion. To cater to this, a new role of a Senior Manager, Process Development has been made available.
Reporting to the Global Headquarters to the VP, Process Development, the Senior Manager will lead a group of 5-6 analytical scientists
- Drive product quality attribute and process development support of commercial Biological and Synthetic products
- Liaise closely and collaborate with leaders from key functions within Process Development, Manufacturing and Quality
- Act as a Process specialist with a holistic chemical / biotech engineering background and experience in the production of drug substance (Cell culture and harvest operations)
- Coordinate multiple, complex, non-routine activities including facility start up, process qualification through to regulatory approval, process performance monitoring, floor support, troubleshooting of unit operations and technology transfer of new processes
- Sustain attribute focused analytical methods, support small scale model and forensics studies, and participate in method transfer activities.
- Provide scientific support for analytical methods in quality control labs, and manufacturing
- PhD/Masters in Biological Sciences, Biochemistry, Analytical Sciences or equivalent with at least 10 years of experience in applying analytical methods in biologics/small molecule development
- Solid understanding of product quality attributes control strategies
- Strong working knowledge of regulatory expectations related to analytical control strategies
- Experience in developing quantitative mass spectrometry methods for characterization, quality control testing and disposition of biologics
- Prior working experience in matrix environment to support CMC development
- Knowledge of Validation Lifecycle Approach and experience in regulatory submissions
- Excellent team management and leadership capabilities
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).