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:
Amgen are looking for 2 Tech Transfer Lead to join their team.
This dedicated technical expert is accountable for leading the management of cross functional activities in Amgen Dun Laoghaire required to successfully and efficiently receive a portfolio of complex drug product manufacturing processes.
The position will be accountable for success of the transfer project from project initiation to the transfer, through regulatory approval.
The position will execute processes on site, per the required technology, characterization, and drug product specific knowledge that will be transferred to the facility.
The lead should ensure that specifications are based on quality, cost and time and will be defined for each product and facility.
This position provides leadership and expertise for operational, scientific and engineering technology, including interface with quality and regulatory policies.
Key Responsibilities will include:
Providing leadership to cross functional technology transfer team which encompasses but is not limited to process/technology and facility readiness including capital project implementation
Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams
Management of timeline to meet the required product quality and process performance
Responsible to deliver against organizational goals and project milestones
Accountable for developing recommendations on potential paths forward and the clear communication of those recommendations and their rationale to project governance including risks of those paths and the risks of alternate pathways
Accountable for devising mitigation strategies for risks of final project pathway chosen
Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance
Ensures that all appropriate groups are represented for decisions that need to be made
Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results
Full understanding of CMC Excellence business process related to technology transfer
Partners with business process owners and Global Networks for business processes related to technology transfer
Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
Requirements
Doctorate degree, Masters degree or Bachelors degree & directly related experience AND Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Preferred Qualifications: -
BS in science, engineering or equivalent
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
Package:
12 month minimum contract
Rate: €45-55/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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Tech Transfer Lead x2 - 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:
Amgen are looking for 2 Tech Transfer Lead to join their team.
This dedicated technical expert is accountable for leading the management of cross functional activities in Amgen Dun Laoghaire required to successfully and efficiently receive a portfolio of complex drug product manufacturing processes.
The position will be accountable for success of the transfer project from project initiation to the transfer, through regulatory approval.
The position will execute processes on site, per the required technology, characterization, and drug product specific knowledge that will be transferred to the facility.
The lead should ensure that specifications are based on quality, cost and time and will be defined for each product and facility.
This position provides leadership and expertise for operational, scientific and engineering technology, including interface with quality and regulatory policies.
Key Responsibilities will include:
Providing leadership to cross functional technology transfer team which encompasses but is not limited to process/technology and facility readiness including capital project implementation
Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams
Management of timeline to meet the required product quality and process performance
Responsible to deliver against organizational goals and project milestones
Accountable for developing recommendations on potential paths forward and the clear communication of those recommendations and their rationale to project governance including risks of those paths and the risks of alternate pathways
Accountable for devising mitigation strategies for risks of final project pathway chosen
Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance
Ensures that all appropriate groups are represented for decisions that need to be made
Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results
Full understanding of CMC Excellence business process related to technology transfer
Partners with business process owners and Global Networks for business processes related to technology transfer
Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
Requirements
Doctorate degree, Masters degree or Bachelors degree & directly related experience AND Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Preferred Qualifications: -
BS in science, engineering or equivalent
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
Package:
12 month minimum contract
Rate: €45-55/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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We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
