Executive AMDM Manager – AR&D CDMO (API)

We are seeking a highly motivated Analytical R&D Scientist with strong experience in CDMO/API analytical development. The candidate will be responsible for developing validating and transferring analytical methods to support late-stage API (Drug Substance) development ensuring regulatory compliance and successful commercial manufacturing.

• Lead analytical method development optimization validation and transfer for APIs/Intermediates supporting Phase 3 and commercial projects.
• Perform method validation verification stability studies impurity profiling and degradation studies in line with ICH guidelines.
• Support process development through analytical troubleshooting characterization and release testing.
• Ensure analytical activities comply with global regulatory requirements (USFDA EMA CDSCO ICH).
• Drive analytical technology transfer from R&D to QC/manufacturing laboratories.
• Review analytical data prepare technical reports validation protocols and regulatory documentation (CTD/DMF support).
• Collaborate with Process R&D QA QC Regulatory Affairs Manufacturing and clients to achieve project milestones.
• Mentor junior scientists and support client audits regulatory inspections and technical discussions.

• Strong expertise in Analytical R&D for API/Drug Substance particularly Phase 3 and commercial development.
• Hands-on experience with HPLC GC LC-MS GC-MS UV IR KF Dissolution and other analytical techniques.
• Proven experience in analytical method development validation transfer stability studies and impurity characterization.
• Sound knowledge of ICH USP EP IP and global regulatory guidelines.
• Excellent analytical troubleshooting project management client communication and leadership skills.

5–15 Years

. / / Ph.D. in Chemistry Analytical Chemistry Pharmaceutical Sciences or a related field.

Required Skills:

API Process Development Process Optimization Technology Transfer Small Molecules Scale-Up Development Reports Batch Records Regulatory Documentation cGMP Quality Standards Cross-Functional Collaboration Troubleshooting Yield Improvement Cost Efficiency Process Chemistry Lab Equipment Process Development Techniques Regulatory Guidelines Documentation Practices Communication Teamwork