Job Description
Summary: Our client, a biopharmaceutical company located in South Dublin, is seeking a Process Scientist (Drug Product). The ideal candidate will be responsible for providing process and product support to drug product formulation and fill-finish operations. (Note: ad hoc shift work may be required for stages of new product introduction). Responsibilities: Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping. Key contributor to product and process investigations, responsible for assessing product and process impact. Leads continuous improvement projects to improve process performance and productivity. Assess product impact associated with proposed changes to commercial processes under the change control process. Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support. Review and approve changes to operating procedures, electronic batch records, and product documentation. Identifies and implements operational opportunities for current and new sterile operations. Risk assessments and mitigation projects relating to line performance. Perform process gap analysis and developing strategies to close gaps. Data trend analysis for all performance aspects of the area. Troubleshooting performance trends. Qualifications & Experience: Minimum of Bachelors or Masters degree in Engineering, Science. Minimum 4 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation Qualification in Lean and 6-sigma methodologies would be an advantage. New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous. Skills: Pharmaceutical technology Biochemical Engineering cGMP