My client is a world leader in the pharmaceutical industry and now seek an experienced API Process Manager to join them. Reporting into the Director of Manufacturing, this position will lead and manage a team of process engineers to provide technical guidance on deviation, investigations and customer complaints.
Responsibilities:
- Assume overall responsibility for process, equipment and cleaning validation on site and maintain expert knowledge in validation life cycle management.
- Manage new products introduction as receiving site and transferring site. Provide technical expertise on site and contract manufacturer site.
- Drive continuous process improvement activities to enhance site performance metrics and contribute to site financial results.
- Provide process support to the site in the areas of manufacturing, plant modifications and CAPEX projects.
- Identify and Implement process/plant optimization and improvements projects to improve yield, process robustness, quality right first time and safety
- Ensure all change activities are managed in compliance with site policies, procedure and regulatory guidelines in GMP and Safety
- Provide resources to support the AIT team on ongoing routine supply manufacturing.
- Proactively monitor the performance of processes by deploying statistical control tools or scientifically proven methodologies
- Provide operation oversight on toll manufacturer activities
- Assume ownership of higher impact and complex issue or complaint and lead deep dive root cause analysis in a timely manner
- Maintain and rigorous work processes in documentation and qualification of all relevant modifications to process related procedures and documents to support filings
Requirements
- Advanced Degree in Chemistry, Chemical Engineering or equivalent
- At least 10 years of professional experience in pharmaceutical/chemical industry with team leading experience
- Strong experience in API Processes
- Sound operational knowledge of chemical process engineering and plant operations
- Experience in projects and team management
- Experience with plant control automated systems
- Knowledge of LEAN support methodologies
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).
