Executive AMDM Manager – CDMO R&D (API)
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Role Overview:
We are seeking a highly motivated Process R&D Scientist with strong experience in CDMO/API development. The candidate will be responsible for developing optimizing and scaling up chemical processes from lab to pilot scale ensuring robust cost-effective and scalable manufacturing routes.
Lead organic synthesis–driven API/Intermediate development focusing on mg-to-kg scale-up to support Phase 3 and commercial readiness.
Drive process optimization scale-up and validation for APIs transitioning from clinical to commercial supply.
Ensure robust reproducible and regulatory-compliant processes for global submissions (USFDA EMA CDSCO ICH).
Oversee technology transfer from R&D to manufacturing sites ensuring seamless handover and compliance.
Guide analytical method development stability studies and impurity profiling for late-stage DS programs.
Collaborate with clients QA/QC regulatory affairs and manufacturing to meet project timelines and quality standards.
Mentor and build a high-performing R&D team focused on innovation efficiency and client satisfaction.
Represent the CDMO in client audits technical reviews and regulatory interactions.
Strong expertise in API/DS development for small molecules especially Phase 3 and commercial scale-up.
Proven track record in process R&D scale-up and validation.
Deep knowledge of global regulatory requirements and late-stage development challenges.
Excellent project management client communication and leadership skills.
PhD/MPharm/MSc in Chemistry Pharmaceutical Sciences or related discipline.
Experience: 5–15 years
Education: / Ph.D in Chemistry or 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
