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QC Engineer (M/F)

June 23rd 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

Mission Description

The QC Engineer main role is to support the team of project leaders with their projects. He/she will support the transfer and development of analytical methods and lead validations in the Quality Control department.

In order to fulfill his/her role, the QC Engineer:

Communication/Mindset

  • The QC Engineer is an active member of the QC management team.
  • Warns the front-end responsible/Head of QC in case of problem

Scientific support on Analytical Methods Transfer/Validation (AMT/AMV), development and investigations:

  • Coaches QC members to AMV and transfer environment (concept of validation, protocols, design of experiments) and statistical analyses associated to QC (ANOVA, bridging, ...)
  • Can take part in the design and review of AMT protocol & report depending on the need
  • Coordinates the different AMV of all the current projects in MTC
  • Is responsible of the AMV/planning and respect of projects deadlines
  • Ensures that the discussed strategy is translated into validation protocol and experimental plan and communicates with Project Leaders (PL) and QC specialists/experts in charge of the method
  • Develops a fit for purpose approach for AMV depending on clinical Phase of the study and requirements of the customer
  • Follows up of experiments related to AMT/AMV and support statistical data analysis
  • Ensures GMP compliance and implementation of MTC’s QMS, product quality and team driven by patient safety
  • Support the project leaders in the technology transfer of QC tests.
  • Support the project leaders in the setup of new QC tests.
  • Suggests new technologies to implement and qualify.
  • Takes part in big project investigations to support teams
  • Could be the project leader of internal projects linked to QC

Budget

  • Determines the impacts of a project scope change on resources and timelines of his/her project(s) and then reports his/her conclusions to Head of QC/Project leader/Project Manager/Business team.  

Audits/prospects

  • Takes part to audits/prospects when necessary.

People Management

  • Supervises and participates in individual development of N-1

Back-up of this function

  • He/she identifies a specific back-up that attends all specific project(s) meetings during his/her absence.(e.g. Project leader or other QC engineer).

Candidate profile

OBLIGATORY REQUIREMENTS

  • At least Bioengineering degree or Master degree in biology, pharmacy, chemistry,...
  • At least years experiences in a cGMP biopharmaceutical environment.
  • Experience in analytical methods validation and statistics.
  • Experience in cell therapy or quality control of cells from human tissue origin is a plus.

USEFUL REQUIREMENTS

  • Efficient communicator
  • Demonstrated leadership
  • Hands-on mentality
  • Quality minded, rigorous
  • Customer oriented
  • Can work in multi projects / multi departments environment
  • Fluency in French and English is a must.

Offer

  • Full-time position (40h/week).
  • An indeterminate contract.
  • The opportunity to take part in a growing dynamic biotech company.
  • A human-sized working environment with a convivial atmosphere.
     

Contact Details

To apply for this job, please send your application on the following link :MaSTherCell