Process Scientist (Drug Product) – Hybrid

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 Bachelor’s or Master’s 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.