I'm looking for...
close

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.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
Connect with me on
Hot Science Jobs
EHS Specialist II
Limerick
Senior Human Factors Engineer
Galway
Continuous Improvement Coach
Limerick
Senior Maintenance Technician
Kilkenny
Product Development Engineer II
Athlone
Quality Technician
Galway
Senior Product Development Engineer
Galway
Director of Regulatory Affairs
Galway
R&D Technician
Galway
Design Quality Engineer
Galway
Manufacturing Technician
Clare
Documentation Specialist
Louth
Quality Control Analyst (shift)
Carlow
Quality Engineer
Galway
Project Manager
Kildare
Design Assurance Engineer
Galway
Senior Principal R&D Engineer
Galway City
R&D Director
Galway
Senior Regulatory Affairs Specialist
Athlone
Project Manager (Pharma)
Dublin
R&D Engineer
Galway
Senior Associate Quality Control
Dublin
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Principal Design Assurance Engineer
Galway
Senior R&D Engineer
Dublin
R&D Engineer
Clare
Quality Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Clare
Product Specialist - Orthopaedic Divisio
Dublin
Quality Engineer - Supplier
Galway
Staff Systems Engineer
Limerick
Senior Quality Assurance Specialist (hyb
Dublin
Principal Design and Development Enginee
Galway
Product Development Engineer
Dublin
Quality Engineer
Wexford
R&D Manager
Galway
Regulatory Affairs Maanger
Galway
Senior Regulatroy Affairs Specialsit
Galway
Product Development Engineer II
Athlone
R&D Manager
Connaught
Quality Manager
Dublin
Senior Equipment Design Engineer
Dublin
Quality Technician
Galway
Health & Safety Specialist
Louth
Senior Research Scientist
Galway
Technical Life Cycle & Engineering M
Galway
Senior Quality Engineer
Dublin
Senior Research Scientist
Galway
Principal Engineer
Dublin
R&D Engineer
Galway
Key Account Manager - Retail UK National
South East
Senior Regulatory Specialist
Cork
Inside Sales Representative (IVD Divisio
Kildare
R&D Engineer
Galway
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
R&D Manager
Connaught
Environmental Health & Safety (EHS)
Longford
Manufacturing Technician
Clare
Quality Specialist
Clare
Manufacturing Technician
Clare
Senior Design Assurance Engineer
Galway
Marketing Manager
Galway
Supplier Quality Engineer
Galway
Project Manager
Galway
Senior R&D Engineer
Dublin
Director of R&D
Limerick
Biomedical Engineer
Dublin
Manufacturing Technician
Galway
R&D Engineer
Dublin
Senior Operations Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
Senior Design Assurance Engineer
Galway
R&D Technician II
Galway
Senior Electronic Engineer
Dublin
Business Development Manager
Republic of Ireland
Warehouse Operator
Dublin
Senior Project Engineer - R&D
Galway
Senior Clean Utilities Engineer
Dublin
Senior R&D Engineer II
Galway
Senior Principal R&D Engineer
Galway City
Senior Project Manager - Fill Finish
Dublin
Validation Engineer
Carlow
Project Engineer
Roscommon
Senior R&D Engineer
Galway
Senior Quality Assurance Associate
Dublin
R&D Director
Galway
R&D Manager
Galway
Quality Assurance Associate
Cork
Biostatistician
Dublin
R&D Manager
Galway
Senior Design Assurance Engineer
Athlone
Quality Manager
Galway
Senior R&D Engineer
Galway
Senior Quality Assurance Specialist
Cork
Senior Research Scientist
Galway
R&D Manager
Connaught
Documentation Specialist
Louth
Commercial Attribute Science Snr Associa
Dublin
Validation & Verification Engineer
Dublin
Senior R&D Manager
Athlone
Senior Product Development Engineer
Galway
Health & Safety Specialist
Dublin
Embedded Software Engineer
Dublin
Senior R&D Engineer
Galway
Senior Principal Design and Development
Galway
Supply Chain Specialist - New Material I
Meath
QA Manager
Canada
Senior Quality Engineer
Dublin
Senior Production Supervisor
Galway City
Project Manager (hybrid)
Dublin
Validation Engineer
Republic of Ireland
Senior Quality Engineer
Dublin
Director of R&D
Galway
Equipment Engineer (Syringe Inspection S
Dublin
Quality Engineer
Galway
Product Development Technician II
Galway
R&D Manager
Dublin
Senior Equipment Design Engineer
Dublin
Quality Specialist
Clare
Senior Design Assurance Engineer
Galway
Senior Research & Development Engine
Limerick
Continuous Improvement Coach
Limerick
Senior Regulatory Affairs Specialist
Westmeath
R&D Manager
Athlone
Principal Software Engineer
Athlone
QC Micro Analyst (4 cycle shift)
Cork
Project Manager
Kildare
Advanced Technologies R&D Manager
Clare
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Process Chemist
Limerick
Senior Design Assurance Engineer
Galway
Staff R&D Engineer
Limerick
Production Manager
Dublin
R&D Manager
Athlone
QA Operations Specialist
Dublin
Principal Design Assurance Engineer
Galway
R&D Engineer
Dublin
R&D Engineer
Galway
Quality Specialist
Tipperary
Quality Engineer
Galway
Senior R&D Engineer
Galway
Laboratory Technician
Carlow
Senior Manufacting Engineer
Republic of Ireland
Senior Equipment Engineer
Dublin
R&D Lifecycle Manager
Connaught
Warehouse Operator
Meath
Quality Engineer
Galway
Senior Technology Transfer Specialist
Dublin
Senior Design Engineer
Dublin
R&D Manager
Galway
Design Assurance Manager
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Design Assurance Engineer
Galway
Design Assurance Program Manager
Galway
Business Development Manager (Hospitals)
Cork
Calibration Technician
Republic of Ireland
CQV /CSV Quality Assurance Specialist (H
Dublin
Accreditation Manager
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
Director of Quality Engineering
Limerick
Sr Principal R&D Engineer
Galway
CTO
Galway
Microbiology Manager
Dublin
R&D Manager
Connaught
Process Development Engineer
Galway
Senior Quality Engineer
Dublin
Senior Quality Engineer
Galway
Senior Process Engineer
Longford
Sr Project Manager - Syringe Fill Engine
Dublin
Senior Technician Quality Control
Carlow
Senior Production Supervisor
Galway City
Quality Engineer
Athlone
Manufacturing Engineer
Galway
Principal Reliability Engineer
Galway
Clinical Trial Manager
Republic of Ireland
Senior R&D Engineer
Galway
Senior R&D Engineer
Dublin
Quality Specialist
Clare
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway City
R&D Engineer
Galway
R&D Senior Program Manager
Galway
NPI Engineer - Hybrid
Dublin
Principal R&D Engineer
Galway
Director Engineering & Supply Chain
Galway
Mechanical Technician
Carlow
Senior R&D Engineer-New Product Deve
Westmeath
Injection Moulding Engineer
Athlone
Senior Electronic Engineer - Regulated M
Galway
Responsible Person (RP)
Republic of Ireland
Senior Quality Assurance Associate
Dublin
Manufacturing Specialist - Investigation
Dublin
Senior QA Specialist
Dublin
Senior QC Associate (Bioassay)
Dublin
Quality Engineer
Galway
Quality Manager - Medical Devices
Limerick City
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Clare
Senior Quality Engineer
Leitrim
Senior Maintenance Technician
Kilkenny
Strategy Associate Director / Director -
Dublin
Principal R&D Engineer
Galway
Quality Systems Manager
Dublin
R&D Director
Galway
CTO
Dublin
Business Manager (Critical Care & Me
Dublin
QA Engineer
Leitrim
Project Engineer - Senior
Cavan
Principal Device Engineer
Dublin
Senior Operations Engineer
Galway
Principal R&D Engineer
Dublin
Biomedical Engineer
Dublin
Operations Manager
Galway
Product Development Technician II
Galway
Senior Process Development Engineer
Dublin
Quality Manager
Galway
R&D Program Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Supplier Quality Engineer
Galway
R&D Director
Galway
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Bioprocess Associate
Louth
R&D Technician II
Galway
Senior Quality Assurance Technical Suppo
Dublin
Senior Regulatory Affairs Specialist
Athlone
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Tech Transfer Lead - Sterile Drug Product


Reference:SMC03954 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project Lead

We’re currently recruiting for an exciting opportunity with a 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.


Key Responsibilities:

  • Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
  • Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.
  • Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
  • The position will report to Process Development Senior Engineer. Moderate international travel might be required during the course of the project.
  • Development of validation plans, process performance qualifications for vial and syringe filling.
  • 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) with a full understanding of CMC business process related to technology transfer.
  • Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
  • Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.

Education & Experience Requirements:
  • 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 OR Associate’s degree & 10 years of directly related experience.
  • Experience in support of Commercial Protein Drug Product 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 (PpK / batch homogeneity) and/or lyophilisation processes.
  • Knowledge of protein biochemistry with regard to 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.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.