Specialist - Process MSAT

Job Summary
We are seeking a dynamic and experienced Team Lead in Process Development to lead and guide the Injectable Process development team in areas of Quality by Design (QbD), Process selection, Scale Up and Technology transfer to Manufacturing, Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO) and ensure product development leads to development of robust manufacturing process throughout the clinical phases and commercial product life cycle.

Roles & Responsibilities

Technology Transfer, Troubleshooting & Continuous Improvement

• Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM).
• Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities.
• Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers.
• Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products.
• Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments.
• Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
• Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
• Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Cleaning Validation: Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments.

Analytical Support:

• Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
• Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives.

Subject Matter Expertise: Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations.