Analytic Development Manager

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will be responsible for leading method development, validation, stability studies, and technology transfer activities. Your role will involve collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. Strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement are crucial for success in this position. **Key Responsibilities:** - Develop, optimize, and validate analytical methods such as HPLC, GC, UV-Vis, and Dissolution in accordance with ICH and regulatory guidelines. - Prepare and maintain validation protocols, analytical reports, and ensure compliance with Good Documentation Practices (GDP). - Oversee method transfer to QC, provide training, and address troubleshooting issues. - Conduct stability studies, prepare data reports, and collaborate with cross-functional teams to support product development. - Investigate and resolve analytical issues including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs). - Maintain up-to-date documentation and ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). - Evaluate vendors and key starting materials (KSMs) and provide insights to management based on findings. **Qualifications Required:** - Strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. - Proven experience in method development, validation, and regulatory compliance. - Familiarity with global pharmaceutical regulations from FDA, EMA, WHO, and ICH guidelines. - Experience in handling regulatory submissions and documentation, excellent problem-solving abilities, and mentoring R&D scientists. - Familiarity with CAPA systems and good documentation practices will be advantageous. (Note: No additional details about the company were provided in the job description),