Technology Development and Integration Manager (TD&I Mgr.)

- (full-time) -

The position:

For the furthermore expanding of our Technology Development (TD) department we have an open position for a TD&I Manager for our sites in Maastricht and Geleen. In this position you are responsible for ensuring scientific and technological consistency of technology improvement, implementation and integration projects according GLP/GMP requirements.

Tasks and responsibilities:

  • Investigate project/process/assay feasibility and provide implementation recommendations during commercial proposal generation for new clients.
  • Guarantee process/assay consistency investigating equipment, material and procedure equivalency during technology transfer or other activities.
  • Lead non-GMP phase of non-compendial assay transfer during technology transfer.
  • Evaluate validation data packages and design validation studies for processes and assays according to GMP requirements.
  • Provide scientific and technical content in both gap analysis and risk assessments.
  • Develop and implement assays, procedures and production processes and related equipment to keep the company at the forefront of the state-of the art cell and gene therapy industry.
  • Ensure adherence of project specific activities with planned timelines and targets.
  • Generate and review laboratory, technical and quality documentation relevant to or resulting from TD activities and report or present it.

Qualifications and skills:

  • MSc or PhD in biotechnology, biosciences, bioengineering.
  • Relevant experience in the field of cell and gene therapy including ideally in assay and process validation within GMP environment in an international setting.
  • Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA) and bioprocess development/implementation approaches (traditional and automated platforms).
  • Broad experience in the field of ex vivo gene therapy with both viral and non-viral vectors.
  • Good understanding of GMP and ATMP regulatory framework, and Technology Transfer.
  • Planning and organizing skills, result driven, flexible, ability to manage independently multiple projects, team player.
  • Good communication skills in English (verbally and written)

Contact information

Visiting Address:
PharmaCell B.V.
Oxfordlaan 70
6229 EV  MAASTRICHT
Netherlands

T: +31 43 35 09910
E: info@pharmacell.nl

Postal Address:
PharmaCell B.V.
P.O. Box 1331
6201 BH  MAASTRICHT
The Netherlands

VAT:
NL8141.20.568.B01
Chamber of Commerce:
14083599