Assistant General Manager Formulation Development (Injectable)

As an Assistant General Manager (AGM) specializing in Injectable dosage forms, your primary responsibility will be the development, scale-up, and validation of both simple and complex formulations for Injectable products. Your focus will be on creating dosage forms compliant with regulations in the US, EU, India, Canada, Brazil, and other markets. Your role is 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. - Develop Injectable dosage forms for various global markets - Scale up and transfer technology for Injectable products across different regions - Design formulation strategies and oversee the drug product development roadmap - Review stability data of products under development and during validation batches - Handle regulatory queries and conduct studies as necessary - Coordinate with internal departments and external vendors for drug product development - Troubleshoot product and process failures, particularly for US, EU, and other markets - Provide technical guidance to subordinates and ensure compliance with laboratory practices and safety regulations - Follow Good Documentation Practices and Data Integrity requirements during GxP operations - Ensure understanding and adherence to Data Integrity requirements and consequences - Review data for compliance with Data Integrity requirements in the context of job responsibilities - Strong technical expertise in Formulation Development, particularly in Injectable dosage forms - Knowledge of regulations in the US, EU, India, Canada, Brazil, and other markets - Experience in scale-up and technology transfer for Injectable products - Ability to troubleshoot product and process failures - Excellent communication and coordination skills with internal departments and external vendors - Familiarity with Good Documentation Practices and Data Integrity requirements during GxP operations,