Analytic Development Manager
Job Description
We are specifically opening this position to people in an Assistant Manager or Team Leader Role who think they are ready for the Next Challenge!
The person filling this role should be meticulous and experienced to lead method development, validation, stability studies, and technology transfer activities at Synnat Pharma , Visakhapatnam. This role involves close collaboration with R&D, QC, and Regulatory teams, supporting product development and compliance with global pharmaceutical standards. The ideal candidate will have strong analytical expertise, leadership skills, and a commitment to regulatory compliance and continuous improvement.
Responsibilities:
Develop, optimize, and validate analytical methods (HPLC, GC, UV-Vis, Dissolution) as per ICH and regulatory guidelines
Prepare and maintain validation protocols, analytical reports, and ensure GDP compliance
Oversee method transfer to QC, provide training, and address troubleshooting
Conduct stability studies and prepare data reports in alignment with regulatory expectations
Collaborate with cross-functional teams (QA, QC, Packaging, Regulatory) to support product development
Investigate and resolve analytical issues including OOS, OOT, and deviations; implement CAPAs
Maintain up-to-date documentation and ensure compliance with GMP/GLP standards
Evaluate vendors and key starting materials (KSMs); provide insights to management
General Expectations and Past Experience:
Strong understanding of analytical chemistry principles, techniques (HPLC, GC, Dissolution, UV-Vis)
Proven experience in method development, validation, and regulatory compliance
Familiarity with global pharmaceutical regulations (FDA, EMA, WHO) and ICH guidelines
Hands-on experience with pharmaceutical quality systems (GMP, GLP)
Skilled in handling regulatory submissions and documentation
Excellent problem-solving abilities using data-driven approaches
Leadership skills with experience in mentoring R&D scientists
Familiarity with CAPA systems and good documentation practices