Assistant General Manager Formulation Development (Injectable)

As an Assistant General Manager (AGM) Formulation Development specializing in Injectable dosage forms, you will be responsible for the development, scale-up, and validation of both simple and complex formulations for Injectable products. Your primary focus will be on creating dosage forms compliant with regulations in the US, EU, India, Canada, Brazil, and other markets. Your key responsibilities will include: - Developing Injectable dosage forms for various global markets - Scaling up and transferring technology for Injectable products across different regions - Designing formulation strategies and overseeing the drug product development roadmap - Reviewing stability data of products under development and during validation batches - Handling regulatory queries and conducting studies as necessary - Coordinating with internal departments and external vendors for drug product development - Troubleshooting product and process failures, particularly for US, EU, and other markets - Providing technical guidance to subordinates and ensuring compliance with laboratory practices and safety regulations - Following Good Documentation Practices and Data Integrity requirements during GxP operations - Ensuring understanding and adherence to Data Integrity requirements and consequences - Reviewing data for compliance with Data Integrity requirements in the context of job responsibilities Your role will be crucial in ensuring the successful development and validation of Injectable dosage forms for multiple markets, requiring strong technical expertise, regulatory knowledge, and attention to detail.,