Engineering , Science, Pharmaceutical & Food

Tech Transfer Engineer – Dun Laoghaire

  • Contract
  • Remote
  • Dublin South
  • 41955312

PE Global is currently recruiting for a Tech Transfer Engineer for a leading multi-national Biotech client based in Dun Laoghaire.

This is an initial 12-month contract position looking for dedicated technical expert is accountable for leading the management of cross functional activities required to successfully and efficiently receive a portfolio of complex drug product manufacturing processes.

 

ROLE:

  • 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 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, 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
  • 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 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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