Job Description

Roles & Responsibilities

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.

Desired Candidate Profile

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or related field.

• 5–10 years of experience in sterile pharmaceutical manufacturing or technology transfer.

• Strong knowledge of aseptic processing, cleanroom operations, and sterile product manufacturing.

• Experience with regulatory requirements (FDA, EMA, WHO GMP).

• Familiarity with process validation and qualification activities.

• Good understanding of risk management tools (FMEA, HACCP).

  
  

Skills & Competencies:

• Strong project management and coordination skills

• Excellent documentation and technical writing ability

• Analytical thinking and problem-solving

• Effective communication across departments

• Attention to detail and compliance-focused mindset

  
  

Preferred Experience:

• Experience in greenfield or facility startup projects

• Exposure to isolator or RABS systems

• Knowledge of sterilization methods (moist heat, dry heat, filtration)

• Experience with technology transfer from international sites