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Job Description
Job Summary
We're seeking a highly skilled Process Development Scientist to join our team at a leading Biopharmaceutical organization based in Dublin.
Key Responsibilities
- Lead new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective.
- Act as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products.
- Develop and characterize drug product processes and transfers technology to commercial drug product sites.
- Identify and implement operational opportunities for current and new sterile operations.
- Troubleshoot issues with drug product processing technologies and equipment.
- Lead and conduct risk assessment for drug product operations and propose/appropriate CAPA.
- Develop and execute validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross-functional team.
- Ensure all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training.
- Assist in the development of any existing validation program to ensure continued compliance to necessary regulations.
- Contribute to product quality assessments and process flow documents.
Requirements
- A third-level Bachelor's degree in Science, Engineering, or a relevant Quality discipline with 5 years' experience in a similar role or Master's degree & 3 years of directly related experience.
- Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation, and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
This is an excellent opportunity for anyone seeking to work in a leading multinational organization that excels in its field.