Downstream MS&T Scientist
Posted 11 hours 49 minutes ago by Quanta Consultancy Services Ltd
Permanent
Full Time
Other
Dublin, Dublin, Ireland
Job Description
Overview 
Downstream MS&T Scientist - Ireland, Dublin, 12 Month Contract. This role is based at a large-scale facility in Dublin and involves working within a fast-paced project environment.
What you'll do- Identify and implement process improvements, e.g., yield and cycle time reduction, through evaluation of process performance using data analytics tools.
- Provide process subject matter expertise for regulatory inspections and interactions with regulatory agencies (e.g., health authority query support, timely responses and data gathering), representing the Cruiserath site.
- Provide on-the-floor support for troubleshooting processing issues and lead manufacturing investigations into process deviations and resolutions.
- Identify or support process improvements (through change control or CAPA) and participate in the implementation of Lean initiatives at the site.
- Minimum BSc or equivalent with at least 5 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry.
- Demonstrated awareness of cGMP compliance and regulatory agency requirements, plus strong oral communication and technical writing skills.
- Good interpersonal skills with the ability to work effectively in a cross-functional global environment, matrix organisation, and in local group settings.
- Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.