Tech Transfer Lead (Junior)

2021-11-09 12:27:312049-03-25Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorOperations & Manufacturing
Start Date
AdvertiserHilda Lynn
Telephone+3539833013
Job Ref#1002247
Job Views171
Description
Tech Transfer Lead (Junior) – Team Horizon
We have an exciting new contract role on offer for our client, who is a leading biopharmaceutical company based in Dublin.As the dedicated technical expert, you will be accountable for leading the management of cross functional activities in the client site required to successfully and efficiently receive a portfolio of complex drug product manufacturing processes.
The position will be responsible 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 course of the project.
 
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  • Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
 
What you will be doing:
  • 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.
  • 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  
  • 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.
 
What you need to apply:
  • Ideally you will have a 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 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
  • 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.
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