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
Engineering Business Manager
Dublin
Senior QC Associate (Bioassay)
Dublin
Senior Design Assurance Engineer
Galway
Process Chemist
Limerick
CTO
Galway
Senior R&D Engineer
Galway
Senior QC Microbiology
Dublin
Principal R&D Engineer
Galway
QC Microbiology Technician
Kildare
Senior QC Associate - Micro
Dublin
Quality Assurance Senior Specialist
Louth
Instrumentation Engineer
Meath
A.I Specialist
Clare
Project Manager
Kildare
Quality Technician
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Quality Technician
Dublin
R&D Manager
Galway
Senior R&D Engineer
Galway
Sr Electrical Engineer
Galway
Documentation Specialist
Louth
Tech Transfer Lead
Dublin
Senior Operations Engineer
Galway
Senior Project Engineer - R&D
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
Graduate Occupational Hygiene Consultant
Kildare
Application Software Engineer
Galway
Senior Product Development Manager
Galway
Quality Manager
Galway
Senior R&D Engineer
Galway
Senior QC Specialist - Equipment & I
Dublin
CTO
Dublin
Calibration Technician
Republic of Ireland
Manufacturing Technician
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Marketing Manager
Galway
Senior Commissioning & Qualification
Roscommon
R&D Engineer
Galway
Industrial Engineer Capacity Planning
Dublin
Senior Quality Engineer
Leitrim
Shift Technician (Injection Moulding)
Kildare
Senior Maintenance Technician
Kilkenny
Embedded Software Engineer
Dublin
Quality Engineer
Galway
Electrical Condition Monitoring Technici
Limerick
Senior Specialist MS&T
Dublin
Quality Assurance Manager
Galway
Senior Project Engineer
Cavan
Senior Regulatory Affairs Specialist
Clare
Principal Device Engineer
Dublin
Quality Assurance Specialist - Tech Tran
Dublin
Senior QA Specialist
Dublin
Injection Molding Engineer
Mayo
Process Engineer
Leitrim
Senior Equipment Design Engineer
Dublin
Senior Electronic Engineer
Limerick
Design Assurance Engineer
Galway
Product Development Manager
Galway
Senior R&D Engineer
Dublin
EAP Portfolio Manager
Republic of Ireland
Senior Quality Engineer
Dublin
R&D Engineer
Clare
Senior R&D Engineer
Dublin
Manufacturing Specialist (Investigation
Dublin
Clinical Advisor - Wound care (Part-time
Dublin
Project Engineer - Senior
Cavan
Senior Maintenance Technician
Kilkenny
Key Account Executive (Hospital Pharmaci
Dublin
Senior Electronic Engineer
Dublin
Distribution Partner Manager (Life Scien
Dublin
Microbiology Manager
Dublin
Health & Safety Specialist
Dublin
Project Engineer
Cork
Pharmacovigilance Manager (Remote)
Republic of Ireland
Software Design Assurance Engineer
Dublin
Senior Process Engineer
Longford
Senior Design Assurance Engineer
Galway
Quality Manager
Galway
Warehouse Operator
Dublin
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Quality Technician
Galway
R&D Manager
Athlone
Product Development Engineer
Dublin
Quality Assurance Specialist
Waterford
EHSS Specialist
Athlone
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Injection Moulding Engineer
Athlone
Quality Engineer - Supplier
Galway
Senior R&D Engineer
Galway
Senior Design Assurance
Galway
Manufacturing Technician
Clare
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Engineer
Longford
R&D Engineer II
Galway
Senior Regulatory Affairs Manager
Galway
Senior Design Engineer
Dublin
Senior Quality Engineer
Galway
R&D Director
Galway
Senior Quality Engineer
Leitrim
Staff Systems Engineer
Limerick
Business Development Manager
Republic of Ireland
Manufacturing Specialist
Dublin
Senior QC Analyst
Republic of Ireland
R&D Lifecycle Manager
Connaught
R&D Manager
Connaught
Production Planner
Kildare
Documentation Specialist
Louth
Senior R&D Engineer
Dublin
Senior R&D Engineer
Limerick
R&D Manager
Athlone
Quality Manager
Galway
Principal Design Assurance Engineer
Galway
Staff R&D Engineer
Limerick
Engineering Shift Technician
Dublin
QA Manager
Canada
Senior Operations Engineer
Galway
Injection Moulding Engineer
Leitrim
Senior Microbiologist
Dublin
Senior Principal Design and Development
Galway
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Advanced Technologies Manager
Galway
Principal Reliability Engineer
Galway
QA Engineer
Leitrim
Website Audit Specialist
Dublin
Product Specialist (Critical Care &
Dublin
Senior Quality Engineer
Leitrim
Manufacturing Technician
Clare
Quality System & Regulatory Affairs
Galway
Senior Clinical Data Analyst
Dublin
Senior Quality Systems Engineer
Galway
Regulatory Affairs Specialist
Cork
R&D Manager
Galway
R&D Engineer
Galway
R&D Director
Galway
Senior Clinical Data Analyst
Dublin
Senior Project Engineer
Cork
Senior Quality Engineer
Galway
Principal R&D Engineer
Galway
Senior QC Associate - Equipment & I
Dublin
Director of Regulatory Affairs
Galway
Senior Electronics Engineer
Limerick
Product Development Engineer
Galway
Senior NPI Engineer - Hybrid
Dublin
Senior R&D Engineer
Galway
Project Manager - New Product Introducti
Dublin
Senior Research and Development Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Senior R&D Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Senior Regulatory Specialist
Cork
Design Assurance Manager
Galway
CQV Engineer
Roscommon
Senior R&D Manager - Lifecycle Manag
Galway
Quality Specialist
Tipperary
Product Specialist (Critical Care &
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior Research and Development Engineer
Galway
R&D Manager
Galway
Automation Engineer
Westmeath
Validation Engineer
Carlow
Principal Engineer
Dublin
R&D Manager
Galway
Documentation Specialist
Louth
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Industrial Designer
Galway
Senior Operational Readiness Associate
Dublin
R&D Director
Galway
NPI Engineer - Hybrid
Dublin
R&D Engineer
Dublin
R&D Manager
Connaught
Senior Production Manager
Cork
R&D Program Manager
Dublin
Project Engineer
Clare
Quality Engineer - Supplier
Galway
Quality Control Analyst (Cell Culture)
Carlow
Endoscope Service Technician (Dublin)
Dublin
Senior Design Assurance Engineer
Galway
R&D Manager
Galway
R&D Director
Galway
Principal R&D Engineer
Galway
Product Development Technician II
Galway
Senior Quality Engineer
Dublin
Equipment Engineer (Syringe filling)
Dublin
Sr Project Manager - Syringe Fill Engine
Dublin
Senior Quality Engineer
Galway
Production Operator
Meath
Sales/Customer Service Administrator
Clonmel
Production Planner
Kildare
Senior Maintenance Technician
Roscommon
Process Development Engineer
Galway
Quality Manager
Galway
Quality Technician
Galway
A.I Specialist
Clare
Analytical Science Associate & Speci
Carlow
Senior Engineering Manager
Galway
R&D Engineer
Galway
Project Manager
Kildare
R&D Manager
Connaught
Tech Transfer Lead - Sterile Drug Produc
Dublin
Electronic Engineering
Dublin
Quality Technician
Dublin
Senior Regulatory Affairs
Galway
Operations Engineer
Galway
Senior Technology Transfer Specialist
Dublin
Principal Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Supply Chain Project Manager (hybrid)
Dublin
R&D Manager
Dublin
Quality Assurance Team Lead
Cork
Senior Reg Affairs Specialist - Post Mar
Galway
Construction Manager - Pharma/Biotech
Dublin
R&D Engineer
Galway
QA Operations Specialist
Meath
Director of R&D
Limerick
Senior Quality Engineer
Leitrim
LIMS Specialist
Tipperary
Quality Control (QC) Technician
Kildare
Senior Quality Engineer
Dublin
Capital Specialist (Laboratory Equipment
Tipperary
A.I Specialist
Clare
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Engineer II
Galway
Quality Specialist
Clare
Operations Manager
Galway
Quality Assurance Associate
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Quality Manager
Galway
Senior Equipment Design Engineer
Dublin
Principal Software Engineer
Athlone
Senior Clinical Data Analyst
Dublin
Senior QC Specialist
Dublin
Senior R&D Engineer II
Galway
Injection Moulding Engineer
Athlone
Quality Assurance Specialist
Carlow
Quality Engineer
Wexford
Senior Design Assurance Engineer
Galway
Product Development Engineer II
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.