Process Development Scientist

Process Development Executive Process Development Lab (Parenteral)

Seeking a skilled and motivated Process Development Executive to support process development (Parenteral), New Product launch campaign, Optimization, and scale-up activities. The role involves ensuring robust process design with adherence to regulatory and compliance standards.

Key Responsibilities :

• Develop, optimize, and scale-up pharmaceutical manufacturing processes
• Conduct laboratory experiments and process feasibility studies
• Support technology transfer activities to pilot and commercial manufacturing units
• Prepare, review, and maintain process development documentation and reports (PDRs)
• Ensure compliance with GMP, EHS, and applicable regulatory guidelines
• Contribute to CTD, DMF, and other regulatory submissions
• Participate in process validation, risk assessments, and troubleshooting activities
• Collaborate cross-functionally with Analytical R&D, QA, Production, and Regulatory Affairs teams
• Provide technical support during pilot and commercial scale batches
• Assist in internal and external audits/inspections as required

• Qualifications : M. Pharm (Mandatory)
• Experience : 02 08 years of relevant experience in Process Development Lab - PARENTERAL (R&D) within the regulatory approved pharmaceutical facility

Preferred Skills :

• Strong understanding of process development and scale-up principles
• Part of new product launch campaign team
• Technology Transfer : R&D to Manufacturing
• Knowledge of regulatory requirements and documentation
• Good analytical and problem-solving capabilities
• Effective communication and teamwork skills