Expiry Date: 02-06-2021
Categories Biotech, Manufacturing / Production
Job Type: Contractor
Senior Scientist Drug Product for Gene Therapies
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, as well as schooling if you are a parent and do not speak the official country languages.
The Hiring and On-Boarding process is done online.
About this Opportunity
My team and I would like to let you know about this very interesting position as it is working on novel AAVs, for a well-established R&D Biotech based in Belgium. They already have established marketed products and the AAVs, will be a new direction for the company.
We are now looking to hire Bio Chem. Engineer to work as a Senior Scientist Drug Product for Gene Therapies to focus on final manufacturing processes including fill / finish.
They are bringing their first VVs into clinic phases and are building their MS&T team, so there are plenty of opportunities to grow and learn!
The Senior Scientist will collaborate with internal and contract laboratories to support development of drug product processes and definition of an AAV production platform for the NMEs in clinical / commercial manufacture as well as, establishment and operation of a development and manufacturing facility for same gene therapy products.
I believe that this role might appeal to you as you will be involved in the development of drug products and production platform for gene therapy assets. As well you will take responsibility to support the management of DP process development and purification.
This is a great opportunity to get into the platform at the beginning and make a bigger impact on the overall strategy because you will be part of a team of engineers and scientists supporting the building and design of the manufacturing facility for Gene Therapy AAV based products.
As the scientific SME for the Drug product development team internally, cross-functionally and with the stakeholders (CDMOs) you will provide your scientific expertise and help to author and review technical documents such as CMC regulatory sections, SOPs, process descriptions or technical reports as well as review studies for development of processes supporting Fist-in human studies through to commercialization for AAV products.
Your Experience & Skills
Our client is looking for a professional who has MSc or PhD in Biology/Biochemistry, or Chemical / Bioengineering or Virology with a minimum of 3 years of experience in a GMP environment working on PD, manufacturing or bioengineering for large molecules.
You will more precisely contribute by:
Excellent technical knowledge of biologics drug product manufacturing, aseptic processing, drug product commercialization, primary pack selection, parenteral product development, process development and scale-up. Experience with AAV manufacturing is highly desired.
Be a drug product development technical subject matter specialist for AAV gene therapy products supporting facility design, growing into an expert for the Quality-by-Design process development, as well as pre-clinical and clinical manufacturing.
Design, approve and review studies for development of processes supporting First in Human studies through to commercialization for AAV gene therapy products.
Author & review technical documents including CMC regulatory sections, process descriptions, study designs, SOPs, technical position papers, & technical reports.
Identify, evaluate, and implement new technologies to improve and refine rAAV purification platforms.
Package and Benefits:
The role is based in Belgium and provides 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 contact Javier Monfort on +44 (0)207 801 3385 or send a full CV to firstname.lastname@example.org in full confidence to receive more details on this role or to hear about other available opportunities. Alternatively, press the red “Apply for position” button and follow the registration process.
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