Process Development Scientist - API Manufacturing

About the Role

Our client, a leading pharmaceutical manufacturer, is seeking an accomplished Process Development Scientist to enhance their Active Pharmaceutical Ingredient (API) manufacturing capabilities in Portsmouth . This role focuses on optimizing chemical synthesis routes and manufacturing processes to ensure efficient, safe, and scalable production of APIs. You will play a critical role in troubleshooting manufacturing issues, implementing process improvements, and ensuring compliance with stringent regulatory standards. This position offers a challenging and rewarding opportunity to shape the future of API production within a cutting-edge pharmaceutical company.

Key Responsibilities

• Develop, optimize, and scale-up chemical processes for API manufacturing .
• Conduct laboratory and pilot-scale experiments to define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Troubleshoot and resolve process-related issues encountered during development and manufacturing.
• Ensure all process development activities comply with cGMP and safety regulations.
• Collaborate with engineering, production, and quality assurance teams to ensure successful technology transfer.
• Author process descriptions, validation protocols, and reports.

Requirements

• M.Sc. or Ph.D. in Organic Chemistry, Chemical Engineering, or a related field.
• Minimum of 4 years of experience in process development within the pharmaceutical or fine chemical industry.
• Strong knowledge of organic synthesis, reaction kinetics, and scale-up principles.
• Experience with process safety assessments and handling hazardous materials.
• Familiarity with cGMP requirements and regulatory guidelines.
• Excellent problem-solving abilities and strong analytical skills.

Benefits

• Competitive salary and bonus structure.
• Comprehensive health and wellness benefits.
• Opportunity to work on diverse and innovative API development projects.
• Hybrid work arrangement providing flexibility.
• Career growth opportunities within a leading pharmaceutical organization.