TD&I Expert

Doorsturen
 
  • Aanbod € 50,000 - € 60,000
  • Functiegroep Research & Development
  • Dienstverband Fulltime, Parttime
  • Vacaturenummer 7959600
  • Locatie Maastricht
  • Contract Detachering via YER
  • Branche Medical & Health, Food, Feed & Pharma

Over deze vacature

For further expansion of the Technology Development (TD) department at Pharmacell, we have one open position for a TD&I Expert. In this position you are responsible for ensuring scientific and technological consistency of technology improvement, implementation and integration projects according GLP/GMP requirements.

Functie

Tasks and responsibilities:
  • Guarantee process/assay consistency investigating equipment, material and procedure equivalency during technology transfer
  • 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
  • Represent TD&I department in internal and external project specific meetings
  • Provide scientific and technical content in both gap analysis and risk assessments
  • 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

Bedrijf

Pharmacell, located in Maastricht, is known as a contract manufacturing organisation in Europe for cell therapy and regenerative medicine.

Aanbod

You will be employed by YER and seconded to Pharmacell. Our benefits are very competitive and designed around your preferences:

  • A competitive salary depending on experience
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Healthy work-life balance

Profiel

Qualifications and skills:
  • MSc or PhD in Biotechnology, Biosciences, Bioengineering
  • Relevant experience in the field of cell and gene therapy (ideally with both viral and non-viral vectors)
  • Strong knowledge of cell characterization techniques (e.g. FACS, qPCR, ELISA)
  • Broad experience in QC assay validation within GMP environment ideally in an international setting
  • Ideally significant experience with Technology Transfer in a GMP environment (Focus on non-compendial Assays)
  • Experience with bioprocess development (traditional and automated platforms) would be a plus
  • Good understanding of GMP and ATMP regulatory framework
  • 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)
Doorsturen