KU Leuven

GENE THERAPY ANALYTICS LEAD

KU Leuven

Leuven, United Kingdom

GENE THERAPY ANALYTICS LEAD

(ref. BAP-2021-758)

Last modification : Friday, November 26, 2021

The Laboratory of Viral Cell Biology and Therapeutics (LVCBT) at KU Leuven is an internationally highly regarded research lab, that is developing AAV gene therapy products in collaboration with industrial partners. The recently exploding interest in gene therapy product development and associated manufacturing challenges, have urged the scientific community to come up with innovative findings in this area. LVCBT is tackling these challenges through the setup of a Gene Therapy Discovery Science team that will support the AAV Manufacturing and GT Product Development team in defining the cutting edge of gene therapy research, development and production. To support these three teams, we are recruiting a highly motivated and skilled researcher to fulfill the role of Gene Therapy Analytics Lead. This person will ensure that the quality of the processes and products remains above industry standards. Moreover, being embedded in a prominent research university, this person will be able to develop creative and innovative technology for gene therapy analytics.
Responsibilities
  • You plan and perform optimization or development of new analytical assays, primarily for quantification of vector genome & capsid titer and assessment of vector purity and integrity This includes q/ddPCR, ELISA, western blot, denaturing gels… but also advanced technologies such as TEM, DLS, AUC, …
  • You develop cellular assays such as transduction assays, vector potency assays, neutralizing antibody assays, TCID50 and asset-specific assays.
  • You perform and/or provide oversight of method qualification and validation of (bio)analytical assays following regulatory guidelines
  • You support both the rAAV Manufacturing and Gene Therapy Discovery Science team in their needs for analytical assessment of crude and purified Gene Therapy products.
  • You identify, develop and validate novel technologies for viral vector analysis, potentially in collaboration with existing and newly identified partners
  • You write and review technical documents, protocols and SOPs
  • You train technical staff how to correctly perform these SOPs and manage their activities.
  • You analyze the data systematically, write reports, and feed this information back to the relevant team members.
  • You are responsible for the quality management regarding product batch releases.
Profile
  • You have a PhD in Sciences, Biomedical Sciences, Bio-engineering or equivalent by relevant experience.
  • You have experience with designing and performing analytical and cellular assays.
  • You have strong affinity for data analysis and quality management.
  • Your experience with viral vectors, especially rAAV, is a plus.
  • You can develop, standardize, and validate protocols, and write them down into SOPs
  • You are interested in novel technologies and instrumentation for viral vector analytical methods.
  • You take responsibility for your analytical data and place your scientific integrity above anything else.
  • You are detail-oriented and communicative. You are pro-active and strive for continuous improvement of yourself and your work.
  • You can prioritize your work and navigate your work in a fast-paced and rapidly evolving research and production environment.
  • You’re fluent in English.
Offer
  • We offer a full-time appointment for one year, with the option to extend
  • A stimulating work environment driven by the ambition to deliver new therapeutics to patients
  • Superb career development opportunities with exposure to R&D in an exciting new therapeutic modality; possibility to interact with international and industrial collaborators
Interested?
For more information please contact Mrs. Ingrid Pintens, tel.: +32 16 37 31 53, mail: ingrid.pintens@kuleuven.be.
You can apply for this job no later than January 10, 2022 via the online application tool
KU Leuven seeks to foster an environment where all talents can flourish, regardless of gender, age, cultural background, nationality or impairments. If you have any questions relating to accessibility or support, please contact us at diversiteit.HR@kuleuven.be.

Please apply via recruiter’s website.