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Technology Transfer Specialist – Sterile Pharmaceutical Manufacturing
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 Employment Type Full Time Company Industry MedicalHealthcareDiagnosticsMedical Devices Department / Functional Area IT Software Keywords ValidationManufacturing Transfer ManagerManufacturing EngineerAseptic ProcessingPharmaceutical ManufacturingTechnology Transfer LeadDeviation ManagementFDAEMAWHO GMPFMEAHACCPSterilization MethodsMoist HeatDry HeatFiltration Get real-time job updates only on our App
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- CompanyConfidential Company
- LocationAbu Dhabi, UAE
- CategoryOther
- SourceNaukrigulf
- Listed13 years ago
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