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

• 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.