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
