HRM are currently working with one of the world's leading biotechnology companies. They are a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. They are seeking an experiences Process Development Manager to join a high-performing and dynamic team at their state-of-the-art facility in South Dublin.
The Process Development Manager will be responsible for technical delivery of NPIs and life cycle management (LCM) products to the site.
Duties and responsibilities of the Process Development Manager will include but are not limited to:
- Lead new product introductions and lifecycle changes into the plant from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
- Manage a team of tech transfer engineers/scientists.
- Be a key contributor to regulatory filings as part of the NPI process.
- 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 through the NPI or post-NPI phases.
- Provide process development expertise for commercial drug product processing.
- Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
- Troubleshoots issues with drug product processing technologies and equipment.
- Development of validation plans, process performance qualifications (PPQs) for vial and syringe filling.
- Ensure that the site meets the quality requirements of its customers and applicable regulations.
- Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.
To be considered, you should have skills and experience in the following:
- BSc in Science, Engineering or a relevant Quality discipline
- 5+ years relevant industry 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
- Knowledge of cGMPs and other worldwide regulatory requirements
- 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
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
- Problem solving ability and excellent oral and written communications skills
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.