We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Swords. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching to associate staff. Provide technical leadership for:Experimental design, execution, data analysis and interpretation.Development, transfer and qualification of assays.Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).Technical point of contact for Process Analytical Technologies (PAT).Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions.Technical lead for characterization testing, ensuring testing conducted either internally or externally.Serving as a key member during internal audits and external inspections/audits.Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus. Education & Experience This role requires an experienced individual with a minimum of 6 years' (for MSc), 8 years' (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.Experience with assay development and qualification of biologics assays (HPLC-based, ELISA, etc). Familiarity with potency assays, including cell-based assays. If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or ****** for further information.
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