Analytic Development Manager

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!

Synnat Pharma

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