LSC have a great contract opportunity for a Tech Transfer Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products. ABOUT THE PROJECT - KEY RESPONSIBILITIES: 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 Alexion 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. ABOUT YOU - ARE YOUR SKILLS A MATCH? 6 years' experience providing technology transfer project support to drug substance or drug product manufacturing. Bachelor's degree in Science or Engineering, (or related field). Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations. For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently. Thank you for your attention. Apply via this advert or contact Adam Murphy at LSC on if you have any more questions about this. Skills: TechTransfer NPI Drug Substance Fill Finish