Senior Formulation Strategist

Job Overview

The Assistant General Manager is a pivotal role in the formulation and development of oral solid and liquid products for various markets, including regulated, semi-regulated, and international territories.

Key Responsibilities:

• Develop strategic plans for new product development based on market needs and customer requirements.
• Oversee pre-formulation and formulation activities using Quality by Design (QbD) to create robust, bioequivalent, and stable products that meet regulatory standards.
• Ensure seamless integration of development activities from lab scale to regulatory filling and commercial launching, with efficient project management and communication among cross-functional teams.
• Prepare strategies and documentation for executing scale-up and End-of-Batch (EB) batches at plant locations, adhering to Good Manufacturing Practices (GMPs).
• Troubleshoot and resolve manufacturing or quality-related issues in accordance with company quality policies and industry best practices.
• Address regulatory deficiencies to achieve timely and early product approval, maintaining compliance with relevant regulations and guidelines.
• Conduct process validation activities and technology transfer of products from lab scale to commercial scale, ensuring smooth transition and minimizing risks.
• Develop alternative sources for Active Pharmaceutical Ingredients (APIs) and excipients to improve cost efficiency and reduce dependence on single suppliers.
• Guarantee that projects are completed on time within budget while meeting all quality and regulatory expectations, demonstrating strong leadership and problem-solving skills.
• Participate actively in meetings with internal stakeholders and external clients, translating technical or strategic input into actionable tasks with monitoring of project progress and performance metrics.
• Contribute to the ideation, conceptualization, and development of novel, innovative, and patentable products that address emerging market trends and customer needs.
• Manage day-to-day team activities, assign tasks, mentor associates, and provide regular feedback to ensure high-performing teams and individual contributor growth.
• Foster strong working relationships with cross-functional teams to drive timely regulatory filing and successful market launch, promoting collaboration and open communication.
• Promote continuous improvement in systems and processes, leading to technical, solution, and cost improvements that enhance competitiveness and customer satisfaction.
• Maintain a positive, transparent, and collaborative team environment, serving as a bridge between the team and upper management to facilitate effective communication and issue resolution.