Are you aJunior Tech Transfer Lead with 10 years of post graduate experience in cGMP manufacturing in a biologics / pharmaceutical / medical device setting? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Tech Transfer Lead - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
Seeking a highly motivated individual to function as a lead member of a commercial drug product technology transfer team.
The successful candidate will report to the technology transfer lead and ensure technology transfer requirements are delivered on time to a high standard.
Key Responsibilities:
Lead the transfer of manufacturing site for a parenteral product throughout the tech transfer lifecycle from planning, development testing, process performance qualification through to regulatory submission.
Review and write tech transfer protocols and assessments, support manufacturing execution of test and qualification runs.
For their assigned product the product transfer lead 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.
Requirements:
B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
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.
Package:
Basic rate of 55 - 60 euro per hour
Minimum Contract duration: 12 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
Are you aJunior Tech Transfer Lead with 10 years of post graduate experience in cGMP manufacturing in a biologics / pharmaceutical / medical device setting? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior Tech Transfer Lead - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
Seeking a highly motivated individual to function as a lead member of a commercial drug product technology transfer team.
The successful candidate will report to the technology transfer lead and ensure technology transfer requirements are delivered on time to a high standard.
Key Responsibilities:
Lead the transfer of manufacturing site for a parenteral product throughout the tech transfer lifecycle from planning, development testing, process performance qualification through to regulatory submission.
Review and write tech transfer protocols and assessments, support manufacturing execution of test and qualification runs.
For their assigned product the product transfer lead 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.
Requirements:
B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
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.
Package:
Basic rate of 55 - 60 euro per hour
Minimum Contract duration: 12 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
