R&D Director – Pharmaceutical Manufacturing

Key Responsibilities:

Strategy & Leadership

• Shape and execute the overall R&D direction in line with business growth goals and client needs
• Oversee the full product development lifecycle, from formulation through to process optimization
• Spearhead innovation efforts to broaden the organization's capabilities across different product forms such as tablets, liquids, and creams
• Recruit, develop, and lead a high-performing R&D team

Product Development & Technology Transfer

• Lead the development of new product formulations based on client specifications
• Manage pilot batch production, scale-up activities, and the handover of developed products to the manufacturing floor
• Ensure smooth collaboration between R&D, Production, Quality Assurance, and Regulatory teams throughout the process
• Provide technical support for troubleshooting issues with existing commercial products

Regulatory & Compliance

• Ensure all R&D activities meet local and international regulatory requirements including FDA, ASEAN, and PIC/S standards
• Review and approve key technical documents such as product dossiers, validation protocols, and study reports
• Support the preparation of regulatory submissions and address technical inquiries from clients and regulatory authorities

Client & Stakeholder Management

• Serve as the main technical point of contact for toll manufacturing clients
• Provide scientific expertise and guidance during product development discussions
• Ensure R&D deliverables are completed on schedule and in line with client expectations
• Quality & Continuous Improvement
• Uphold strict adherence to GMP, GLP, and internal quality standards across all R&D activities
• Identify and implement improvements that enhance efficiency, reduce costs, and shorten turnaround times
• Establish and promote best practices in formulation and analytical development

Qualifications & Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field; Master's or PhD is preferred
• Licensed Pharmacist is highly preferred
• At least 12–15 years of experience in pharmaceutical R&D, with a minimum of 5 years in a leadership capacity
• Strong background in a toll manufacturing or CDMO (Contract Development and Manufacturing Organization) setting is highly preferred
• Proven track record in formulation development, scale-up, and technology transfer
• Deep knowledge of regulatory frameworks including FDA, ASEAN, PIC/S, and GMP
• Demonstrated ability to manage multiple client accounts and projects simultaneously