Technology Transfer Lead – Biologics GMP
- Contract Type
We have a hugely exciting opportunity exclusively available as a Technology Transfer Specialist at a fresh and novel biopharmaceutical manufacturing facility based in Poland. This is a fantastic chance for an experienced tech transfer specialist to move into a dynamic and challenging position where you can have a real impact into the development of the organisation.
Previous experience in a CDMO/Biopharmaceutical manufacture/ GMP environment (5-7 years approx)
Previous Technology Transfer experience (2+ year’s at least)
Experience with Regulatory agencies/ IND would be advantageous but not necessarily required
Project Management experience again would be advantageous but not necessarily required
Document writing ability
Performing technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determining scope/design of technical batches and engineering batches for transfer
Providing input into overall project strategy and plans including timelines
Contributing to process improvement and optimization for process transfers
Establishing procedures and templates for technology transfer
Forming and leading project teams
Supporting creation of Master Batch Record
Participating in R&D and Production meeting for process development and process transfer
Organizing the R&D, QC/QA and Production meeting for process development and process transfer
Ensuring site readiness for campaign start-up
Leading Technology Transfer – from external companies to internal or internally from internal pipeline R&D to manufacture.
Establish project plans and relaying internally for implementation
Review and support of Quality Risk Assessment (QA) prior to transfer and prior to validation
Defining pre-validation and validation strategy
Writing manufacturing process transfer documents
By clicking “apply” you will be sending your CV to Simon Trebilcock at Barrington James. Simon is a Specialist European Pharmaceutical Recruiter with 5 years recruitment experience, an MSc in Molecular Biology and a BSc in Chemistry. Simon will discuss the opportunity in detail with you facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role.
This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to “Simon” at strebilcock (at) barringtonjames (dot) com alongside a copy of your CV.