Tech Transfer Engineer

3 weeks ago


County Dublin, Ireland Life Science Consultants (LSC) Full time

LSC have a great contract opportunity for a Tech transfer Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you ABOUT THE PROJECT - KEY RESPONSIBILITIES: * Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the site. * Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles: o Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill. * Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. * To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools. * To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale ABOUT YOU - ARE YOUR SKILLS A MATCH? * Minimum BSc or equivalent with at least 3 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities. * You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills. * Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings. Skills: Tech Transfer PPQ Process Improvements Lean 6 Downstream



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