R&D Sr.Chemist

Job description

Senior Chemist R&D Job Description **Position:** Senior Chemist Research & Development (R&D) **Department:** R&D **Location:** Nakkapalli **Reports To:** R&D Manager Job Summary The Senior Chemist R&D is responsible for developing, optimizing, validating, and transferring pharmaceutical formulations and analytical methods from laboratory scale to commercial manufacturing. The role ensures compliance with GMP, regulatory requirements, and company quality standards while supporting product development, technology transfer, and continuous improvement activities. Key Responsibilities Analytical Development - Develop and validate analytical methods using HPLC, GC, UV, Dissolution, and other instruments. - Perform method transfer to QC laboratories. - Investigate OOS (Out of Specification) and OOT (Out of Trend) results. - Analyze stability samples and generate reports. Technology Transfer & Scale-Up - Support scale-up activities from lab to pilot and commercial production. - Prepare technology transfer documents and manufacturing instructions. - Troubleshoot process-related issues during exhibit and validation batches. - Coordinate with Production, QA, QC, and Regulatory Affairs teams. GMP & Regulatory Compliance - Ensure compliance with cGMP, GLP, data integrity, and regulatory guidelines. - Prepare SOPs, specifications, protocols, reports, and validation documents. - Support audits and regulatory inspections. - Maintain accurate laboratory documentation and batch records. Documentation & Reporting - Prepare development reports, protocols, validation reports, and scientific presentations. - Maintain project timelines and update management on project status. - Review laboratory notebooks and technical documents. Team Leadership - Mentor junior chemists and research associates. - Train staff on GMP, laboratory safety, and analytical techniques. - Drive continuous improvement and innovation initiatives. Required Qualifications - M.Sc. Chemistry / Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry. - B.Pharm / M.Pharm (Pharmaceutics, Pharmaceutical Analysis) may also be considered. - 510 years of experience in pharmaceutical R&D, formulation development, or analytical development within a GMP-regulated environment. Technical Skills - Strong knowledge of GMP, GLP, ICH, FDA, WHO, and EU guidelines. - Hands-on experience with HPLC, GC, UV, Dissolution, FTIR, Karl Fischer, etc. - Expertise in method development, validation, and stability studies. - Experience in technology transfer and process scale-up. - Good understanding of pharmaceutical manufacturing processes. Key Competencies - Problem-solving and root-cause analysis. - Scientific data interpretation. - Project management and planning. - Technical report writing. - Leadership and cross-functional collaboration. - Strong communication and documentation skills. KPIs - Successful product development and commercialization. - Timely completion of projects. - Regulatory compliance and audit readiness. - Reduction in formulation/process-related deviations. - Effective technology transfer and scale-up success rate. - Team productivity and training effectiveness. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.