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Technology Development and Integration Manager - Netherlands  

PharmaCell (company)


Posted on : 10 April 2017

Project Description

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 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, bio sciences, bio engineering. 
  • 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)