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Jefferson Wells
Jefferson Wells

Process & Analytical Development Expert

Published on Jobat.be 18 days ago

Process & Analytical Development Expert

#cellstherapy #Process development #Scientist #Biotechnology 

The objective is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market.

To help lead its increasing number of development and manufacturing projects, our partner is looking for a highly motivated Process & Analytical Development Expert.

Job description

What are your responsibilities?  

 

Expert’s responsibilities need to be adapted according to the development phase of the project from early process and analytical development, technical transfer to GMP or QC.

  • You can be involved in all stages of production process maturity (from development or acquisition to continuous commercial GMP production) and follow up of closed projects.
  • You will deal with technology, productions and team management.
  • You will generate and ensures finalization documentation (procedures/instructions/forms/protocols) to perform specific production, or generic documentation which could be eventually approved by the Team Leader and relevant stakeholder prior to production start.
  • You will follow and compiles KPIs of his/her team and feed continuous improvement of the P&AD team;
  • You will generate and/or ensures finalization and/or approves of all documentation related to performed process and analytical development for final approval by hierarchy/certified reviewer.
  • Upon specific request, you will represent the project that you manage to internal/external meetings.
  • You will ensure cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
  • You will ensure your team is adequately staffed, trained, equipped to execute required work
  • You will take a special care to continuously train colleagues working in GLP environment and manages all area monitoring.
  • You will support change control preparation and derogation.
  • You will generate product investigations related to OOS opened by QC.
  • You will be involved in preparation and execution of any audits/inspection.
  • You will act as a scientific referent to Process & Analytical Development Specialist

Profile

Who are you?  

 

You have a master’s or PhD degree in biology, biomedical sciences, biochemistry or clinical chemistry. You have good knowledge of production in a GMP/commercial context with, if possible, a background in a development/industrialization context. You are able to benchmark with people who have analytical or process knowledge You are results and problem solving oriented. You have a good team spirit. You can handle multitask, and you are flexible. You are fluent in French and English

Offer

What can you expect?  

Jefferson Wells offers you a permanent contract within a growing and dynamic biotech company. You will work in a human-sized working environment with convivial atmospheres and scientific challenges. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marine Chauvelot, marine.chauvelot@jeffersonwells.be.

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    10 days left to apply

    Characteristics

    Requirements

    • Master (University or Higher Education Long Type)
    • French

    Offer

    • Fixed-term
    • Independent
    • Full-time

    Apply before

    • 21 May

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