Production Chemist
Sanofi
Singapore, , SingaporePosted Discovered via the company's careers siteMatch locked
Regular1+ years exp
About the role
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
.
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
•
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.
Not included in the source posting: benefits.
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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