Executive AMDM Manager – CDMO R&D (API)

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