QA Micro Associate CAR T Gent M/V/X

Description de l'entreprise

Are you ready to be part of an innovative and hardworking venture that is changing the
landscape of blood cancer treatment? CAR-T therapy harnesses the patient's own immune
system to combat cancer cells, providing hope to those who have exhausted other
treatment options. As we are expanding our capacity for CAR-T treatments in Europe, we are
seeking dedicated individuals to join

Description de la fonction

As a QA Micro Associate, CAR-T Europe, you will play a pivotal role in ensuring the microbiological and aseptic oversight of the production of autologous CAR-T products for clinical trials and commercial operations, which takes place in a controlled cGMP cleanroom environment, fostering contamination control and adhering to industry-specific regulations.

This position is based in Ghent, Belgium.

Profil

Education/Experience:

A minimum of a Bachelor's Degree in Engineering, Science, or an equivalent technical field.

Experience in the biological and/or pharmaceutical industry, with relevant micro experience related to manufacturing.

Key Capabilities, Knowledge, And Skills:

l Aseptic processing in an ISO 5 cleanroom and biosafety cabinets.

l Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to cell-based product manufacturing.

l Detailed knowledge of shop floor manufacturing processes.

l Strong organizational skills with the ability to work effectively in a team environment and a positive attitude.

l Excellent written and verbal communication skills in English.

l Record-keeping abilities in the form of notebooks, technical reports, and protocols.

l Ability to summarize and present results, and experience with team-based collaborations.

l Proactive, solution-oriented mindset with the ability to explore new paths and identify possibilities.

l Accept diversity as an asset.

l Ability to follow procedures and guidelines, even in ambiguous situations.

Collaborate with the Process Development team, Quality, and Operations organization to uphold contamination control of the manufacturing facility in alignment with cGMP and Janssen requirements.

l Conduct aseptic qualifications of manufacturing personnel, including gowning and aseptic processing.

l Define and impart specific aseptic techniques for crucial process steps through instructor-led trainings and awareness sessions.

l Drive the Aseptic Oversight program through manufacturing floor surveillance.

l Support process microbiological investigations actively.

l Develop relevant quality control documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs).

l Maintain, re-evaluate, and communicate key critical inputs for the site's environmental monitoring program.

l Identify risks and opportunities related to contamination control, collaborating closely with operators, Quality Control (QC), and operations management on improvement initiatives.

l Perform tasks in compliance with safety policies, quality systems, and cGMP requirements.

Compétences linguistiques

• Néérlandais (atout)

  • Comprendre : Indépendant - (B1)
  • Écrire : Indépendant - (B1)
  • Lire : Indépendant - (B1)
  • Parler : Indépendant - (B1)

Avantages du poste

(BE0402725291)

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