My client is a leader in the biotechnology space and now are going through a phase of rapid expansion. To cater to this, they now seek an experienced MSAT Process Specialist to join them
This role will be reporting to the Head of MSAT
- Assume primary responsibility for technical support to manufacturing operations to ensure that processes meet cGMP requirements
- Lead data collection, process monitoring, deviation closure, process troubleshooting, and optimization activities related to manufacturing
- Demonstrate knowledge and understanding of pharmaceutical processing and associated cell culture and harvest unit operations including equipment operation, design and control
- Provide floor support, troubleshoot unit operations, and resolve and document investigations to support cGMP production
- Ensure timely closure of deviations, change control and qualification activities.
- Support quality, process development and manufacturing operations in ensuring the process control strategy is maintained and monitored
- Lead and assist in process troubleshooting and process monitoring trending systems and tools that align with the QMS and are part of the process verification plan
- Maintain strong working relationships with inter-department stakeholders as well as external contractors
- Mentor junior process engineers and specialists
- Advanced Degree in Engineering, Biotechnology or equivalent with at least 7 - 10 years of relevant working experience
- Experience with cell therapy and upstream/downstream process will be a big plus
- Prior experience in process troubleshooting, deviation writing and executing change controls, particularly in a clinical or commercial manufacturing setting.
- Comprehensive experience in cGMP quality systems including process monitoring, non-conformances, change controls and CAPA
- Familiar with Six Sigma Methodologies
- Travel of about 20%
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).