Tech Transfer Specialist

Team Horizon is seeking a Tech Transfer Specialist for our client based in Dublin. The Technical Operations team support the global manufacturing operations across both internal and external sites. The TO team delivers expert technical leadership process ownership and rapid solutions to ensure delivery of product pipeline and product technical leadership post-commercialisation. The position requires effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Why you should apply :

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• Excellent contracting rates on offer. What you will be doing :
• Developing and implementing TT Strategy including Process Validation, Control Strategy.
• This includes drug substance and drug product (biologic) and small molecule drug substance and drug product (e.g. oral solid dosage)
• Leading technical gap assessment & ensuring implementation of any associated mitigation activities. Authoring and reviewing project related documentation.
• Reviewing approving supporting protocols and reports. Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with global requirements. Provide SME input to technical aspects of IR response.
• Providing support to Regulatory audits as needed. Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements. What you need to apply :
• 6 years’ experience providing technology transfer project support to drug substance or drug product manufacturing.
• Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations.
• Comprehensive understanding of Technical / cGMP requirements for Tech Transfer activities.
• Ability to present and defend tech transfer topics during regulatory agency inspections.
• Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
• Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations