
Manufacturing Excellence Lead
3 days ago
Job Title:
- Process Optimization Specialist
Job Description:
- The Process Optimization Specialist delivers technical support to the Drug Substance Business, leading investigations and supporting significant projects across the site.
- This role is responsible for driving compliance of Global Policies, Procedures and Guidelines, regulatory requirements and executing current Good Manufacturing Practices (cGMP) in day-to-day activities.
Key Responsibilities:
- Design and execute qualification documentation in line with standard process.
- Lead experimental design of studies, execution, data analysis and interpretation.
- Interpret trends observed in commercial process monitoring and drive improvements to yield and/or robustness.
- Support development and PPQ batches, change control management and implementation.
- Lead multidisciplinary teams for process improvement and troubleshooting using Lean Six Sigma methodologies.
- Participate in audits and inspections, and lead various site initiatives to improve compliance status and operational efficiency.
Requirements:
- Strong analytical and problem-solving skills.
- Excellent communication and team leadership skills.
- Knowledge of process monitoring systems, automation systems and operational intelligence & data systems within a GMP manufacturing environment.
Essential Qualifications:
- Bachelor degree in a scientific or engineering field.
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation.
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