The Production Chemist provides technical and process support for the manufacture of Active Pharmaceutical Ingredients (APIs), working closely with the Production team to ensure the safe, compliant and efficient operation of manufacturing processes.
The role applies sound chemistry and chemical engineering principles to troubleshoot process issues, improve process robustness, optimize efficiency, quality and yield, and support the lifecycle management of manufacturing and cleaning processes.
The incumbent will also provide technical support to other site functions as required and contribute to continuous improvement, technology transfer, validation and process safety activities.
Reporting Relationship
Reporting to the Production Support Manager, the Production Chemist will be a key member of the Production team and will work cross-functionally with Manufacturing, MSAT, Quality, Continuous Improvement, Engineering and HSE teams.
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.
Pursue progress, discover extraordinary
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