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

Role Overview:

We are seeking a highly motivated Process R&D; Scientist with solid 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.

Key Responsibilities

- 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.

Candidate Profile

- 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: M. Sc / Ph.D in Chemistry or 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 – CDMO R&D (API) (India)
🏢 Talental Consultings
📍 India