The Technical Transfer Officer is responsible for leading and coordinating the transfer of pharmaceutical products from R&D to commercial manufacturing sites, ensuring full compliance with GMP requirements and regulatory standards.
The role plays a strategic part in process optimization, cost efficiency, and external partner management (CMOs/CDMOs). The position requires strong cross-functional collaboration with R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain to ensure successful product industrialization and lifecycle management.
Job Requirements:
Education: Bachelor’s, Master’s, or PhD degree in: Pharmaceutical Sciences, Chemistry, Biotechnology, Industrial Pharmacy, Or a related scientific field
Experience: 2 or 3 years of experience in the pharmaceutical industry.
Languages:
• Fluent in English (written and spoken).
Technical Competencies:
• Bsic knowledge of cGMP regulations and pharmaceutical compliance requirements.
• Understanding of manufacturing processes (solid, liquid, sterile forms as applicable).
• Knowledge of documentation management and good documentation practices.
• Familiarity with quality systems (deviations, CAPA, change control).
Personal Competencies:
• Good communication and stakeholder management abilities.
• Strong analytical and problem-solving skills.
• Ability to influence cross-functional and external teams.
• High level of organization and attention to detail.
• Resilience and ability to perform under pressure in complex environments.
• Change management capability and continuous improvement mindset.
Duties and Responsibilities:
• Support the coordination and execution of technology transfer activities from R&D to manufacturing sites.
• Assist in the preparation, review, and archiving technical transfer documentation (protocols, reports, batch records, risk assessments).
• Ensure documentation compliance with GMP and internal quality standards.
• Coordinate communication between R&D, Production, Quality Assurance, Regulatory Affairs, and external partners (CMOs/CDMOs).
• Monitor transfer timelines and follow up on action plans to ensure project milestones are met.
• Support process validation activities (PPQ, cleaning validation, equipment qualification).
• Participate in risk assessments and gap analyses during transfer projects.
• Assist in change control, deviation management, and CAPA follow-up related to transfer activities.
• Contribute to data collection, analysis, and reporting during scale-up and industrialization phases.
• Support supplier visits, audits preparation, and technical meetings.