Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
Google Chrome |
Internet Explorer |
Mozilla Firefox |
Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Dublin
Westmeath
Carlow
Tipperary
Westmeath
Dublin
Dublin
Dublin
Cork
Galway
Tipperary
Athlone
Galway
Clare
Athlone
Galway
Athlone
Dublin
Westmeath
Dublin
Galway
Leitrim
Germany
Tipperary
Carlow
Clare
Offaly
Carlow
Dublin
Cork
Galway
Galway
Tipperary
Leitrim
Dublin
Limerick
Limerick
Limerick
Republic of Ireland
Dublin South
Galway
Dublin
Dublin
Dublin
Galway
Republic of Ireland
Tipperary
Republic of Ireland
Dublin
Tipperary
Dublin
Carlow
Wexford
Cork
Dublin
Galway
Longford
Republic of Ireland
Galway
Louth
Galway
Republic of Ireland
Dublin
Carlow
Limerick
Cavan
Athlone
Dublin
Carlow
Tipperary
Wexford
Carlow
Galway
Carlow
Limerick
Wexford
Dublin
Carlow
Galway
Athlone
Dublin
Carlow
Tipperary
Dublin
Limerick
Tipperary
Dublin South
Dublin
Carlow
Leitrim
Galway
Dublin
Dublin
Carlow
Dublin
Carlow
Galway
Carlow
Dublin
Galway
Tipperary
Roscommon
Galway
Louth
Tipperary
Carlow
Limerick
Dublin
Dublin
Carlow
Limerick
Athlone
Leitrim
Limerick
Canada
Dublin
Clare
Limerick
Galway
Galway
Galway
Limerick
Republic of Ireland
Galway
Limerick
Carlow
Dublin
Carlow
Galway
Dublin
Cork
Republic of Ireland
Dublin
Dublin
Carlow
Dublin
Westmeath
Republic of Ireland
Dublin
Tipperary
Athlone
Athlone
Leitrim
Limerick
Dublin
Dublin
Tipperary
Dublin
Cork
Athlone
Dublin
Cork
Dublin
Dublin
Republic of Ireland
Galway
Waterford
Galway
Galway
Galway
Dublin
Republic of Ireland
Westmeath
Dublin South
Tipperary
Galway
Carlow
Cork
Carlow
Carlow
Cork
Carlow
Dublin
Dublin
Dublin
Galway
Galway
Dublin
Limerick
Galway
Carlow
Galway
Galway
Galway
Limerick
Carlow
Galway
Carlow
Dublin South
Dublin
Carlow
Carlow
Dublin
Galway
Republic of Ireland
Dublin
Westmeath
Dublin City Centre
Dublin
Leitrim
Republic of Ireland
Galway
Westmeath
Dublin
Clare
Athlone
Dublin
Limerick
Dublin
Tipperary
Dublin
Galway
Tipperary
Technical Transfer Specialist
Reference: | SMC43856 | Location: |
Dublin |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
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.
• Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response 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 propose / implement appropriate CAPA.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development and execution of validation plans, process performance qualifications (PPQs) for vial and syringe filling with a cross functional team.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Contribute to product quality assessments and process flow documents.
• Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated product.
• Lead or assist in deviation and exception resolution and root cause analysis.
Education & Experience
• 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
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS