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Job Description
Seeking experienced biologics analytics and characterization expert to provide technical leadership and support various initiatives within a multinational biopharmaceutical organization.
Job Description
We're currently recruiting for an exciting opportunity with a leading multinational biopharmaceutical organization based in Swords.
- 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.
- 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 for process improvement and troubleshooting with end-to-end product focus.
Requirements
- Minimum of 6 years' (for MSc), 8 years' (for BSc) directly related experience in academia, pharmaceutical or biotechnology company.
- 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.