Job Details: Senior Project Manager


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Senior Project Manager


Are you an experienced Project Manager with Tech Transfer knowledge?  Do you have ca 8-10 years 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 Project Manager - Tech Transfer - 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

Very familar with MS Project 2010.

8-10 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 - 65  euro per hour

Minimum Contract duration: 8 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 an experienced Project Manager with Tech Transfer knowledge?  Do you have ca 8-10 years 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 Project Manager - Tech Transfer - 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

Very familar with MS Project 2010.

8-10 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 - 65  euro per hour

Minimum Contract duration: 8 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

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