Job Title: Research Scientist – Process R&D

Department: R&D – Process Development

Industry: CDMO / API

Purpose of the Role:

To lead and execute the development, optimization, and scale-up of robust, cost-effective, and regulatory-compliant chemical processes for Active Pharmaceutical Ingredients (APIs) and intermediates, ensuring smooth technology transfer from lab to kilo lab and manufacturing.

Key Responsibilities

1. Strategic Responsibilities

• Drive innovation by designing synthetic routes that align with project timelines and regulatory requirements.
• Contribute to technology differentiation strategies that enhance the CDMO’s scientific credibility and client value proposition.
• Collaborate with cross-functional teams (Analytical, QA/QC, Regulatory) to support integrated drug development solutions.

2. Operational Responsibilities

• Perform route scouting, literature search, and develop robust and scalable chemical processes using QbD principles.
• Conduct laboratory experiments for reaction optimization, impurity profiling, and process safety assessment.
• Prepare and review technical reports, SOPs, and technology transfer documents.
• Ensure compliance with GMP/GLP and EHS standards during lab-scale and pilot-scale operations.
• Participate in troubleshooting during scale-up or commercial production batches and provide technical support during client audits.

3. Financial Responsibilities

• Optimize process economics by reducing cycle time, yield improvement, and minimizing raw material costs.
• Support cost estimation activities during project proposals or client RFQs by providing technical insights.

4. People & Collaboration Responsibilities

• Guide junior team members on experimental planning, data interpretation, and documentation best practices.
• Promote a culture of safety, learning, and innovation within the team.
• Work closely with Program Management and Business Development to align project goals with customer expectations.

Qualifications & Experience

• M.Sc ( Organic Chemistry)
• 3–9 years of experience in Process R&D, preferably in CDMO organizations
• Hands-on expertise in synthesis, scale-up, impurity profiling, and technology transfer
• Familiarity with analytical techniques (HPLC, GC, NMR) and regulatory documentation