Production Chemist

TheProduction Chemist provides technical and process support for the manufacture ofActive Pharmaceutical Ingredients (APIs), working closely with the Production team to ensure the safe, compliant and efficient operation of manufacturing processes.

The role applies soundchemistry 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 theProduction Support Manager, the Production Chemist will be a key member of the Production team and will work cross-functionally withManufacturing, MSAT, Quality, Continuous Improvement, Engineering and HSE teams.

Key Accountabilities

Process Support & Optimization

• Provide day-to-day technical and process support forAPI manufacturing operations.
• Optimize and improve manufacturing processes to enhanceefficiency, 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.
• LeadContinued Process Verification (CPV) and trend analysis ofCritical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and process yield.
• Develop and implementprocess robustness strategies in collaboration with Continuous Improvement Specialists, Quality and MSAT.
• Support and/or leadroot cause analysis (RCA) for process robustness deviations using structured problem-solving methodologies such asDMAIC.
• Drive continuous improvement initiatives across manufacturing and process operations.

Process & Cleaning Lifecycle Management

• Support and/or leadproduct and cleaning lifecycle management activities.
• Drive continuous improvement and optimization ofcleaning processes.
• Prepare, coordinate and implementprocess 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 ofProcess Analytical Technology (PAT) models and maintenance of PAT instrumentation.
• Assist in the preparation, review and maintenance ofproduction and process procedures, technical documents and supporting documentation.
• Ensure modifications to plant, processes and procedures are appropriately reviewed from aprocess chemistry perspective, with all relevant documentation updated accordingly.
• Prepare and conductprocess-related training for the Operations team.

Technology Transfer

• Participate in thetechnology 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 insafety reviews and audits covering process laboratories, manufacturing processes and equipment.
• Participate inHAZOP 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 applicableHSE and Quality policies, cGMP requirements and established site procedures.

Knowledge & Experience Required

Education

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

Experience

• Minimum1–3 years of relevant experience within anAPI manufacturing plant, MSAT (Manufacturing Science & Technology) function or related chemical industry.
• Hands-on experience in aprocess support or process development laboratory.
• Exposure to pharmaceutical or chemical manufacturing operations is preferred.

Technical Knowledge & Skills

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

Pursueprogress, discoverextraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch ourALL IN video and check out our Diversity Equity and Inclusion actions atsanofi.com!