Job
Description
Position: Head of Analytical Development and Lead (ADL) Location: Rajkot Job Overview: The Head of Analytical Development and Lead (ADL) will be responsible for overseeing the analytical method development, validation, and transfer processes within the pharmaceutical industry. This role involves leading a team of analysts, ensuring that analytical methods for drug substances, intermediates, and raw materials are developed and validated in compliance with regulatory guidelines. The ADL Head will also provide technical expertise in troubleshooting, optimizing methods, and ensuring adherence to GMP, ICH, and other relevant standards. Key Responsibilities: Leadership & Team Management Lead and manage the Analytical Development team, providing guidance, mentorship, and performance management to ensure continuous team development. Foster a collaborative and high-performance culture to achieve departmental and organizational goals. Ensure proper training and development opportunities for team members, ensuring alignment with regulatory standards and industry best practices. Method Development & Validation Develop, validate, and transfer analytical methods for drug substances, intermediates, and raw materials, ensuring alignment with regulatory guidelines (e.g., ICH, GMP). Optimize analytical methods for improved accuracy, precision, and efficiency. Prepare validation protocols and lead the execution of validation studies, ensuring proper documentation and reporting of results. Generate and maintain comprehensive validation reports for regulatory submissions and internal purposes. Regulatory Compliance & Troubleshooting Ensure all analytical methods are developed and validated according to regulatory guidelines (e.g., ICH, GMP). Review and respond to regulatory queries related to analytical methods and data. Troubleshoot analytical issues, identifying root causes and implementing corrective actions to address any problems encountered during method development or validation. Support the preparation of responses to regulatory queries, ensuring compliance with relevant standards. Collaboration & Cross-Functional Support Collaborate with R&D, Regulatory Affairs, Process Development, and Manufacturing teams to support product development and lifecycle management. Provide technical support for technology transfer activities, ensuring smooth transition of analytical methods from development to commercial manufacturing. Work closely with cross-functional teams to ensure analytical methods meet product development timelines and regulatory requirements. Continuous Improvement Lead efforts to improve existing analytical methods and optimize laboratory processes. Implement best practices and continuous improvement initiatives in analytical development to increase efficiency, reduce costs, and improve the quality of the final product. Stay up-to-date with the latest developments and technologies in the field of analytical chemistry and pharmaceutical sciences. Key Skills and Competencies: In-depth knowledge of analytical techniques such as HPLC, GC-HS, UV-Vis, FTIR, and other instrument testing . Expertise in analytical method development, validation, and transfer for drug substances, intermediates, and raw materials. Familiarity with regulatory guidelines and standards , including ICH and GMP . Strong troubleshooting skills, with the ability to identify root causes of analytical issues and resolve them effectively. Experience with deviation management , change control , OOS (Out of Specification) , incident handling , and CAPA (Corrective and Preventive Action) processes. Proficiency in SOP preparation and ensuring compliance with internal and regulatory standards. Excellent project management skills , with the ability to prioritize and manage multiple tasks simultaneously. Strong collaboration skills , with the ability to work cross-functionally with R&D, Regulatory Affairs, Process Development, and Manufacturing teams. Qualifications: Educational Qualification: M.Sc. or B.Pharm or equivalent in Chemistry, Analytical Chemistry, Pharmaceutical Sciences , or a related scientific discipline. Experience: Minimum 8+ years of experience in analytical method development, validation, and transfer in the pharmaceutical industry. Regulatory Knowledge: In-depth understanding of regulatory guidelines (e.g., ICH, GMP) and experience in responding to regulatory queries . Industry Experience: Significant experience in the pharmaceutical industry , specifically in analytical development for drug substances, intermediates, and raw materials. Preferred Skills: Knowledge of advanced analytical techniques and emerging technologies in the pharmaceutical industry. Familiarity with regulatory submissions , including DMF (Drug Master File) , and experience with regulatory inspections . Previous experience in technology transfer activities in a GMP-compliant environment.
