Scientist - MSAT

Responsibilities

• Finalize manufacturing processes and critical process parameters (CPPs) for scale-up, validation, and commercial batches
• Manage technology transfer processes, including procurement of API, excipients, and equipment
• Coordinate with internal departments such as R&D, Production, Quality Control, and Regulatory Affairs to ensure seamless transfers
• Support Regulatory Affairs with NDA/ANDA filing activities and respond to regulatory queries
• Prepare and review technical documents, including study protocols, reports, SOPs, and Batch Manufacturing Records
• Provide technical troubleshooting and ongoing support to the manufacturing team for process validation and continuous improvement
• Perform data stratification and trend analysis for Critical Quality Attributes (CQAs) to control process drift
• Ensure strict compliance with cGMP/cGLP standards and organizational safety procedures

Requirements

• Ph.D., M. Pharm, or M.Sc. with at least 4 years of relevant experience
• Proven experience in Formulation Development, Process Development, or Technology Transfer of sterile injectable formulations
• Experience in plant technology transfer support for injections, including process validation for regulated markets
• Strong understanding of DMAIC methodologies
• Proficiency with Minitab tools and principles such as PHP/IMEx
• Effective verbal and written communication skills

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering breakthroughs that change patients' lives. We leverage cutting-edge design and process development capabilities to accelerate the delivery of best-in-class medicines to patients worldwide.