Technology Transfer Specialist – Sterile Pharmaceutical Manufacturing

Confidential Company

An international pharmaceutical manufacturing company based in UAE is seeking a Technology Transfer Specialist who is responsible for planning, coordinating, and executing the transfer of sterile pharmaceutical manufacturing processes from R&D or external sites into the production facility. This role ensures smooth scale-up, compliance with regulatory requirements, and successful validation of aseptic processes, equipment, and systems.

Key Responsibilities:

• Lead technology transfer activities for sterile products (injectables, ophthalmic, etc.) from development or external manufacturing sites.

• Review and analyse technology transfer documents including batch manufacturing records, process descriptions, and analytical methods.

• Coordinate with cross-functional teams (R&D, QA, QC, Production, Engineering) to ensure seamless transfer.

• Support process scale-up, optimization, and troubleshooting during initial batches.

• Prepare and review Technology Transfer Protocols (TTP) and Technology Transfer Reports (TTR).

• Ensure compliance with cGMP, aseptic processing standards, and regulatory guidelines (e.g., FDA, EMA).

• Participate in process validation, media fills, and equipment qualification (IQ/OQ/PQ).

• Identify risks and implement mitigation strategies during transfer activities.

• Provide technical support during commercial manufacturing startup.

• Ensure proper documentation, change control, and deviation handling.

• Support regulatory submissions by providing required technical data.