Technology Transfer Specialist (Biopharma)

Summary:

A Technology Transfer Specialist is required for a biopharmaceutical manufacturing company located in West Dublin. The ideal candidate will provide technical leadership and project support for technology transfer activities across drug substance and drug product manufacturing. The role will involve developing and implementing technology transfer strategies, including process validation and control strategy, while ensuring compliance with cGMP requirements. The successful candidate will work cross-functionally with Manufacturing, MS&T, Process Development, Engineering, Quality, Regulatory and Supply Chain to ensure successful transfer, validation and lifecycle management of manufacturing processes.

Responsibilities:

• Develop and implement Technology Transfer (TT) strategies, including Process Validation and Control Strategy for drug substance and drug product manufacturing, including biologics and oral solid dosage forms.
• Lead technical gap assessments and ensure implementation of associated mitigation plans to support successful process transfer and validation.
• Author and review technology transfer documentation, including project plans, protocols, reports, validation documentation and supporting technical documentation.
• Review and approve supporting protocols and reports in line with site and regulatory requirements.
• Ensure site-specific Cleaning Validation and Media Fill strategies, where applicable, are aligned with global and regulatory expectations.
• Provide subject-matter expertise in support of investigations, including input to regulatory inspection responses and audit readiness activities.
• Support regulatory inspections by presenting and defending technology transfer and validation approaches as required.
• Collaborate with cross-functional teams to ensure alignment between sending and receiving sites during technology transfer activities.
• Support the implementation of technology transfer and validation best practices across the network and contribute to continuous improvement initiatives.
• Ensure compliance with cGMP, regulatory and site requirements throughout all stages of technology transfer and validation.

Qualifications & Experience:

• Bachelor’s degree in Science, Engineering or a related discipline.
• Minimum 6 years’ experience supporting technology transfer projects within drug substance and/or drug product manufacturing environments.
• Proven experience managing technology transfer programmes at site level and/or corporate level in support of GMP operations.
• Comprehensive understanding of cGMP and regulatory requirements relating to technology transfer and validation activities.
• Experience in biopharmaceutical bulk drug substance manufacturing and aseptic fill-finish operations.
• Strong knowledge of current industry practices and regulatory guidelines, with demonstrated ability to interpret and apply regulatory expectations.
• Experience presenting technical content during regulatory inspections is highly desirable.
• Strong technical writing skills and ability to author and review complex validation and regulatory documentation.