Expiry Date: 07-05-2021
Category Regulatory Affairs
Job Type: Full Time
Gene Therapy USP Lead
Relocation: This role is in Belgium and comes with full relocation. If Covid still runs, they will bring you over and you will initially work from a temporary apartment until you find your own place, at their expense and cost. You will benefit from a relocation package which includes tickets, logistics, removals and a settling in allowance. The Hiring and On-Boarding process is done online.
About this opportunity:
I would like to let you know about this exciting new role for a well-known R&D Biotech company based in Europe with many late phase programs and marketed products and now looking to hire a Gene Therapy Process Sciences Upstream Lead.
This is a global Biotech with existing small and large molecules already registered leaving a successful track record in registering products including mAbs and now, they intend to bring their VVs into clinic in the next 12 months, hence they are building their MS&T team.
The most interesting part of this role is that you will be part of the team that holds responsible for the development and production of rAAV gene therapy assets and will lead the USP team to support the Gene Therapy programs by helping to build the concept design of the facility and the QbD process development.
It is a great opportunity to get into the platform at the beginning and make a bigger impact on the strategy and process by supporting the pre-clinical and clinical manufacturing as well as the hiring process to make the team grow and develop the new Gene Therapy pipeline.
You will act as the SME and Leader for the USP team internally, cross-functionally and with the stakeholders (CDMOs) providing your scientific expertise and helping to author and review technical documents such as CMC regulatory sections, SOPs, process descriptions or technical reports.
Your experience and skills:
Our client is looking for an individual who has MsD or PhD in Biology/Biochemistry, Chemical/Bioengineering or Virology with a minimum of 3 years of experience in a GMP environment working on PD, manufacturing or bioengineering with solid knowledge on biologics upstream manufacturing (flask and bioreactor cell culture).
Previous experience in hiring will be taken into account as well, as the role will require you to scout and retain talent for the USP team and good understanding in English both spoken and written is mandatory, and in French would be desirable.
Package and Benefits:
The role is based in Belgium and they do provide a relocation support program, digital hiring process during Covid and temporary housing with a disturbance allowance and a really decent package with 48 days off a year!
To apply for this role, please press the red “Apply for position” button, or contact Javier Monfort on +44 (0)207 801 3385 in full confidence to receive more details on this role.
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