Production Chemist

Key Accountabilities

Process Support & Optimization

• Provide day-to-day technical and process support for API manufacturing operations.
• Optimize and improve manufacturing processes to enhance efficiency, quality, robustness and yield, including performing laboratory studies in the process laboratory where required.
• Troubleshoot chemical processing and manufacturing issues and support timely resolution to minimise operational impact.
• Lead Continued Process Verification (CPV) and trend analysis of Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and process yield.
• Develop and implement process robustness strategies in collaboration with Continuous Improvement Specialists, Quality and MSAT.
• Support and/or lead root cause analysis (RCA) for process robustness deviations using structured problem-solving methodologies such as DMAIC.
• Drive continuous improvement initiatives across manufacturing and process operations.

Process & Cleaning Lifecycle Management

• Support and/or lead product and cleaning lifecycle management activities.
• Drive continuous improvement and optimization of cleaning processes.
• Prepare, coordinate and implement process and cleaning validation activities.
• Ensure process and cleaning strategies remain robust, compliant and suitable throughout the product lifecycle.

Process Technology & Technical Documentation

• Support the development of Process Analytical Technology (PAT) models and maintenance of PAT instrumentation.
• Assist in the preparation, review and maintenance of production and process procedures, technical documents and supporting documentation.
• Ensure modifications to plant, processes and procedures are appropriately reviewed from a process chemistry perspective, with all relevant documentation updated accordingly.
• Prepare and conduct process-related training for the Operations team.

Technology Transfer

• Participate in the technology transfer of chemical processes to and from other manufacturing sites.
• Support technical assessments, process knowledge transfer and implementation activities to ensure successful and compliant transfer of manufacturing processes.

Process Safety, HSE & Compliance

• Participate in safety reviews and audits covering process laboratories, manufacturing processes and equipment.
• Participate in HAZOP studies and process safety analyses to identify and mitigate potential process risks.
• Promote safe working practices and proactively communicate safety expectations across areas of responsibility.
• Ensure all activities comply with applicable HSE and Quality policies, cGMP requirements and established site procedures.

Knowledge & Experience Required

Education

• Bachelor's degree in Chemistry or Chemical Engineering – Required

Experience

• Minimum 1–3 years of relevant experience within an API manufacturing plant, MSAT (Manufacturing Science & Technology) function or related chemical industry.
• Hands-on experience in a process support or process development laboratory.
• Exposure to pharmaceutical or chemical manufacturing operations is preferred.

Technical Knowledge & Skills

• Basic understanding of process chemistry and chemical engineering principles.
• Hands-on knowledge of API manufacturing technologies and plant operations.
• Experience or working knowledge of Continued Process Verification (CPV) methodologies.
• Understanding of CPPs, CQAs, process yield and process robustness.
• Knowledge of process and cleaning validation principles.
• Basic understanding of process control and automated systems used within pharmaceutical manufacturing.
• Familiarity with root cause analysis and structured problem-solving methodologies, such as DMAIC.
• Understanding of cGMP, HSE and process safety requirements.
• Strong analytical, troubleshooting and problem-solving capabilities.
• Ability to collaborate effectively with cross-functional teams in a manufacturing environment.

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