Executive/ AM/DM/ Manager – AR&D CDMO (API)

Job Title: Executive / Sr. Executive / AM / DM / Manager – Analytical R&D (CDMO/API)

Role Overview

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.

Key Responsibilities

• 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.

Candidate Profile

• 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.

Experience

5–15 Years

Education

M.Sc. / M.Pharm / Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.

. Skillset Required: 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