LSC require a Technical Transfer Lead for our biotech client based in Dun Laoghaire, Dublin. As part of the Process Development – NPI group this dedicated technical expert will be be accountable for success of the transfer project from project initiation to the transfer, through regulatory approval and will execute processes on site, per the required technology, characterization, and drug product specific knowledge that will be transferred to the facility. This position provides leadership and expertise for operational, scientific and engineering technology, including interface with quality and regulatory policies.
Your primary responsiblities will include:
o Providing leadership to cross functional technology transfer team which encompasses but is not limited to process/technology and facility readiness including capital project implementation.
o Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams
o Management of timeline to meet the required product quality and process performance Responsible to deliver against organizational goals and project milestones
o 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
o Accountable for devising mitigation strategies for risks of final project pathway chosen
o Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance
You will have :
o Doctorate degree, Master’s degree or Bachelors degree
o Direct experience managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
o Minimum 5 years’ experience in technical transfer in biotechnology, leading development and execution of cross functional, complex technical projects
o Experience with molecule commercialization through commercial licensure
o Knowledge of development of commercial processes and process characterization
o Strong technical skills related to scale up
o Thorough knowledge of GMP biotechnology manufacturing
o Solid understanding and knowledge of cGMPs
o Awareness and understanding of quality and regulatory industry trends, policies and guidelines
Please contact Kathy for full details on this role or apply directly through this advert.