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Contact Info
Alexa Tralla
Life Science

+353 1 507 9255
alexa.tralla@lifescience.ie
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Details

Tech Transfer Senior Lead (Contract)


Reference:AT/HQ00001911 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Temporary ContractSalary: Not Disclosed

Overview: Seeking a highly motivated individual to function as a key member of a commercial drug product technology transfer team. The successful candidate will report to the technology transfer lead, within the Process Development Group, and ensure technology transfer requirements are delivered on time to a high standard.


Key Responsibilities:
• Act as a key team member in the transfer of manufacturing site for a parental product throughout the tech transfer lifecycle from planning, development testing, and process performance qualification through to regulatory submission.
• Review and write tech transfer protocols and assessments, support manufacturing execution of test and qualification runs.



One tech transfer lead will be involved in :

• For their assigned product(s) the product transfer engineer will support all aspects of the manufacturing process from end-to-end, from raw material release through formulation and filling to inspection, testing and release.



The other tech transfer lead will be involved in :

• For their assigned product(s) the tech transfer engineer may support all aspects of the manufacturing process from end-to-end, but with particular focus on the manual and automated inspection process.

Basic Requirements:

• B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
• 5 – 10 years of post-graduate experience in cGMP manufacturing in a biologics / pharmaceutical / medical device setting
• Demonstrated ability to work with others in order to meet tight deadlines in a cross functional team environment.
• Demonstrated experience in identifying and resolving complex technical issues.
• Strong technical writing and communication skills.
• Solid working knowledge of cGMP’s, GDP, GLP etc.
• Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines, e-beam decontamination, automated and manual visual inspection is a strong plus.
• Experience with technology transfer is a strong plus.
• Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products and associated microbial, biochemical and biophysical analytical methods is a strong plus.
• Demonstrated experience in identifying and resolving complex technical issues.



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


Alexa Tralla | Tel: +353 (0) 1 507 9255