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.
Seeking candidates with a degree in Science, Engineering or equivalent Strong Microsoft Office Skills
Experience in statistical analysis tools is a plus
Experience in biotechnology, leading development and execution of cross functional, complex technical projects
Experience with molecule commercialization through commercial licensure
Knowledge of development of commercial processes and process characterization
Strong technical skills related to scale up
Thorough knowledge of GMP biotechnology manufacturing
Solid understanding and knowledge of cGMPs
Awareness and understanding of quality and regulatory industry trends, policies and guidelines
Proven track record of advancement in an established, high performing organization
Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs
Ability to lead effectively in an highly matrixed organization
Ability to make tough decisions
Ability to work with ambiguity
Excellent communication and management skills
Excellent project management skills
Ability to make and drive decisions based on cross functional input
Strong understanding of validation of biopharmaceutical facilities, equipment and process
Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately
Ability to work with and communicate effectively with executive management
Strong influencing and negotiation skills
Experience in biotechnology, leading development and execution of cross functional, complex technica
Package:
12 month minimum contract
Rate: €50-60/hour dependant on experience
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
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Senior Tech Transfer Lead - Amgen
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.
Seeking candidates with a degree in Science, Engineering or equivalent Strong Microsoft Office Skills
Experience in statistical analysis tools is a plus
Experience in biotechnology, leading development and execution of cross functional, complex technical projects
Experience with molecule commercialization through commercial licensure
Knowledge of development of commercial processes and process characterization
Strong technical skills related to scale up
Thorough knowledge of GMP biotechnology manufacturing
Solid understanding and knowledge of cGMPs
Awareness and understanding of quality and regulatory industry trends, policies and guidelines
Proven track record of advancement in an established, high performing organization
Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality and regulatory affairs
Ability to lead effectively in an highly matrixed organization
Ability to make tough decisions
Ability to work with ambiguity
Excellent communication and management skills
Excellent project management skills
Ability to make and drive decisions based on cross functional input
Strong understanding of validation of biopharmaceutical facilities, equipment and process
Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately
Ability to work with and communicate effectively with executive management
Strong influencing and negotiation skills
Experience in biotechnology, leading development and execution of cross functional, complex technica
Package:
12 month minimum contract
Rate: €50-60/hour dependant on experience
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
