Are you a Tech Transfer Lead with 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.
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
This dedicated technical expert is accountable for leading the management of cross functional activities in the 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.
The position will report to the Executive Director of Process Development and be located in Amgen Dun Laoghaire.
Moderate international travel might be required during the course of the project.
Responsibilities:
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:
Basic Qualifications:
Doctorate degree, Master?s degree or Bachelor?s 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:
Basic rate of ?50 - 55 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 a Tech Transfer Lead with 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.
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
This dedicated technical expert is accountable for leading the management of cross functional activities in the 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.
The position will report to the Executive Director of Process Development and be located in Amgen Dun Laoghaire.
Moderate international travel might be required during the course of the project.
Responsibilities:
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:
Basic Qualifications:
Doctorate degree, Master?s degree or Bachelor?s 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:
Basic rate of ?50 - 55 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
