R&D Director – Pharmaceutical Manufacturing

R&D Director – Pharmaceutical Manufacturing

Philippines, Laguna, Philippines

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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

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