Process Development Scientist

Process Development Executive – Process Development Lab (Parenteral)

S eeking 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