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Job Description
Seeking a highly skilled Process Development Specialist to lead new product introductions and lifecycle changes in a fast-paced Biopharmaceutical environment.
We're currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. 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:
- Leads new product introductions and lifecycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
- Contributes to regulatory filings as part of the NPI process throughout the authoring, editing and submission process and responds to regulator questions as and when required.
- Acts 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 through the NPI or post-NPI phases.
- Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
- Identifies and implements operational opportunities for current and new sterile operations.
- Troubleshoots issues with drug product processing technologies and equipment.
- Leads and conducts risk assessment for drug product operations and proposes / implements appropriate CAPA.
- Develops and executes validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross functional team.
- Ensures all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensures that the site meets the quality requirements of its customers and applicable regulations.
- Assists in the development of any existing validation program to ensure continued compliance to the necessary regulations.
- Pre-approves and post-approves process validation protocols and assessments from a quality system documentation perspective.
- Contributes to product quality assessments and process flow documents.
- Liaises with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated product.
- Leads or assists in deviation and exception resolution and root cause analysis.
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. Knowledge of protein biochemistry regarding chemical and physical stability.