Job Purpose

Lead pharmaceutical product development from formulation and process development through scale-up and technology transfer, ensuring technical, quality, manufacturing and registration readiness.

Key Responsibilities

 Product & Process Development

• Lead formulation and process development, including material selection, optimization and packaging compatibility.
• Lead development of oncology and injectable products, including sterile processing and lyophilization where applicable.
• Assess technical feasibility and resolve formulation/process-related issues.

 Scale-up & Technology Transfer

• Lead pilot batches, scale-up and technology transfer from R&D to Production.
• Ensure processes are robust, reproducible and suitable for commercial manufacturing.
• Work with Production, QA and QC on troubleshooting, deviations and technical risks, particularly for sterile, cytotoxic and/or highly potent products.

Quality & Registration Support

• Coordinate with QC on analytical methods, specifications and stability studies.
• Review development data and technical documentation.
• Provide technical support to RA for registration dossiers and regulatory queries.

R&D & Project Management

• Manage R&D projects, timelines, resources and laboratory activities.
• Manage, coach and develop R&D team members while providing hands-on technical guidance.
• Ensure GMP, data integrity, laboratory safety and proper documentation.
• Monitor project progress and report key technical issues and risks to management.

Requirements

Education

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences or a relevant scientific discipline.
• Master’s or PhD is an advantage.

Experience

• 7+ years of hands-on pharmaceutical R&D/product development experience.
• Current or prior experience as R&D Manager, Deputy R&D Manager or Assistant R&D Manager, preferably in a strong local pharmaceutical company.
• Proven experience in managing, coaching and developing R&D team members.
• Strong experience in formulation, process development, scale-up and technology transfer.
• Experience in injectables and/or oncology products is strongly preferred.
• Sterile processing, lyophilization and/or cytotoxic/high-potency experience is an advantage.

Skills

• Strong pharmaceutical development and GMP knowledge.
• Strong technical problem-solving and troubleshooting skills.
• Good project management and people management skills.
• Strong hands-on technical capability and cross-functional collaboration.