
Chemical Process Engineer
17 hours ago
Job Title: Development Specialist
About the Role:
We are seeking an experienced Development Specialist to lead and execute the development, optimization, and scale-up of robust, cost-effective, and regulatory-compliant chemical processes for Active Pharmaceutical Ingredients (APIs) and intermediates.
Main Responsibilities:
- Process Development:
- Design synthetic routes that align with project timelines and regulatory requirements.
- Contribute to technology differentiation strategies that enhance our scientific credibility and client value proposition.
- Collaborate with cross-functional teams (Analytical, QA/QC, Regulatory) to support integrated drug development solutions.
- Laboratory Operations:
- Perform route scouting, literature search, and develop robust and scalable chemical processes using QbD principles.
- Conduct laboratory experiments for reaction optimization, impurity profiling, and process safety assessment.
- Prepare and review technical reports, SOPs, and technology transfer documents.
- Ensure compliance with GMP/GLP and EHS standards during lab-scale and pilot-scale operations.
- Participate in troubleshooting during scale-up or commercial production batches and provide technical support during client audits.
- Process Economics:
- Optimize process economics by reducing cycle time, yield improvement, and minimizing raw material costs.
- Support cost estimation activities during project proposals or client RFQs by providing technical insights.
- Team Leadership:
- Guide junior team members on experimental planning, data interpretation, and documentation best practices.
- Promote a culture of safety, learning, and innovation within the team.
- Work closely with Program Management and Business Development to align project goals with customer expectations.
Qualifications & Experience:
- M.Sc (Organic Chemistry)
- 3–9 years of experience in Process R&D, preferably in CDMO organizations
- Hands-on expertise in synthesis, scale-up, impurity profiling, and technology transfer
- Familiarity with analytical techniques (HPLC, GC, NMR) and regulatory documentation
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