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
Contact Info
Quality Engineer
Limerick
API Purchaser
Dublin
CSV Engineer
Dublin
QA Specialist
Dublin
Process Engineer
Limerick
Senior Social Work Practitioner
Republic of Ireland
Quality Engineer
Dublin South
Quality Manager
Dublin South
Biostatistician
Dublin City Centre
Program Manager
Westmeath
R&D Engineer
Dublin
Administration Support
Dublin North
QC Trainer
Cork
R&D Engineer
Dublin
Risk Manager
Dublin
Consultant
Cork
CTO
Galway
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 applications@lifescience.ie
Details

External Manufacturing Manager


Reference:PORA005597 Location: Limerick
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Consistently ranked as a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies, our client offers a unique, world-class opportunity. A candidate with strong external manufacturing experience is required to join this dynamic team as either an Associate Manager, Manager or Senior Manager.

The External Manufacturing Manager has responsibility for the operation of clinical and commercial parenteral drug product manufacturing in the External Manufacturing Network. They coordinate all aspects of manufacturing operations including overseeing day-to-day operations, technology transfer, new technology introduction, issue resolution, relationship management, and supply fulfilment at drug product manufacturing sites.

Responsibilities

  • Serve as the primary operations contact for select Drug Product manufacturing sites.
  • Oversee production on site, co-ordinate the activities at Drug Product manufacturing sites to meet supply requirements.
  • Coordinated all DP Manufacturing operations at contract and/or business partner manufacturing sites, including but not limited to: scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, track and monitor cycle times, technology transfer execution and providing any required associated reports and technical expertise.
  • Ensure the timely routing and review of all master manufacturing records (MRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at drug product manufacturing sites and/or business partners.
  • Travel to contract manufacturers or business partners, as required. Ability to travel up to 50%.


The Person


  • BS/BA in Life Sciences or a related field and 6 – 8 years of industry relevant work experience.
  • Aseptic Parenteral Filling operations or development experience.
  • Previous experience providing technical support and interacting with Contract Manufacturing organisations.
  • Good interpersonal, cross-cultural, communication, negotiation and problem solving skills
  • Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)
  • Project management (PMP or equivalent) qualification preferable.







If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265