Technology Development and Integration Expert(TD&I Expert.) for project LSFM4LIFE

- (full-time) -

The position:

As part of our participation in the EU funded project LSFM4LIFE (http://lsfm4life.eu/), we have one open position for a TD&I Expert within our Technology Development (TD) department. In this position you are responsible for ensuring successful achievement of Lonza Netherlands Deliverables within the EU project.

This opening would be ideal for profile with relevant experience in a research setting aiming at transitioning toward an industrial career. More junior profile might be considered as TD&I Associate for this position.

Tasks and responsibilities:

  • Investigate process and assays feasibility and provide scientific and technical content in both gap analysis and risk assessments.
  • Develop and provide implementation and scale up recommendations for both assays and processes focusing on translation of product from preclinical into clinical stage (under GMP).
  • Ensure adherence of project specific activities with planned timelines and targets.
  • Generate and review project related documentation and reports relevant to or resulting from TD activities

Qualifications and skills:

  • MSc or PhD in biotechnology, biosciences, bioengineering or regenerative medicine.
  • Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA) and bioprocess development/implementation approaches (traditional and automated platforms).
  • Strong Understanding of GMP and ATMP regulatory framework, and product development throughout clinical stages (from preclinical to commercial).
  • Relevant experience in the field of cell and gene therapy including in assay and process development within GMP environment in an international setting
  • Relevant experience in diabetes and therapeutic approaches based on ATMP will be a plus
  • Relevant experience with European funded research projects will be a plus
  • Planning and organizing skills, result driven, flexible, ability to manage independently multiple projects, team player.
  • Able to manage priorities, under stress and at short notice
  • Excellent communication skills in English.(verbally and written)

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet