Title: Junior Tech Transfer Lead
Location: Dun Laoghaire
This dedicated technical expert is accountable for leading the management of cross functional activities in the company required to receive a portfolio of complex drug product manufacturing processes successfully and efficiently. 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. Moderate international travel might be required during the project.
- 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 company 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.
Qualifications and Experience:
- 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.
- BSc 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 as process development, manufacturing, quality, and regulatory affairs.
- Ability to lead effectively in a 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.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.