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
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

Technical Transfer Specialist - Remote


Reference:SMC3495 Location: Republic of Ireland
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization. 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

  • Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
  • Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
  • Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
  • Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
  • Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
  • Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
  • Responsible for participation in creating, sharing, and adopting best practices and business process strategies.


Education & Experience

  • Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field..
  • Must Have Drug Substance Technical Transfer Experience for this role (4/5 Years).
  • Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
  • Demonstrated ability to independently manage projects/work to schedule/deadlines
  • Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  • Experience in deviation management and/or change control and/or equipment support, and/or project management.



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