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 robust 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

📌 Executive/ AM/DM/ Manager – AR&D CDMO (API) (India)
🏢 Talental Consultings
📍 India