Process Chemist

TalentBridge is seeking a skilled Process Chemist to join our team in the pharmaceutical industry. As a Process Chemist, you will play a critical role in the development, optimization, and scale-up of manufacturing processes for tablets and encapsulated products.

• Process Development: Develop and optimize manufacturing processes for the production of tablets and encapsulated products, ensuring scalability and reproducibility.
• Process Optimization: Conduct laboratory experiments to evaluate and improve process parameters, formulations, and technologies.
• Collaboration: Collaborate with formulation scientists, analytical chemists, and manufacturing engineers to transfer processes from the laboratory to pilot and commercial scale.
• Process Validation: Perform process validation activities, including the design and execution of validation protocols, and analyze data to ensure compliance with regulatory requirements.
• Troubleshooting: Investigate and troubleshoot process-related issues, identifying root causes and implementing corrective and preventive actions (CAPAs) to resolve issues and prevent recurrence.
• Documentation: Prepare technical reports, batch records, standard operating procedures (SOPs), and other documentation to support regulatory filings and manufacturing operations.
• Regulatory Compliance: Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory standards and guidelines.
• Project Participation: Participate in cross-functional project teams, providing expertise in process chemistry and contributing to the overall success of product development and manufacturing projects.
• Continuous Improvement: Stay current with industry trends, advancements in process technologies, and regulatory changes, and apply this knowledge to drive process improvements and innovation.

• Education: Bachelor's degree in Chemistry, Chemical Engineering, or related field; advanced degree (M.S. or Ph.D.) preferred.
• Experience: 2-5 years of experience in pharmaceutical process chemistry, with a focus on tablet and encapsulation manufacturing.
• Knowledge: Strong knowledge of pharmaceutical manufacturing processes, including granulation, blending, compression, coating, and encapsulation.
• Skills: Experience with process development, optimization, and scale-up from laboratory to commercial production; familiarity with regulatory requirements and guidelines (e.g., FDA, ICH, GMP) related to pharmaceutical manufacturing.
• Analytical and Problem-Solving Skills: Proven ability to conduct root cause analysis, implement CAPAs, and troubleshoot process-related issues.
• Communication and Interpersonal Skills: Excellent technical writing skills, with the ability to prepare detailed reports, SOPs, and regulatory documentation; strong analytical and problem-solving skills, with a detail-oriented approach to work.
• Software Proficiency: Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and experience with laboratory and manufacturing software systems.