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Microbiology QC Supervisor (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

RESPONSIBILITIES

The microbiology QC supervisor main role is to supervise the activities linked to microbiology in the Quality Control department. These activities are divided in these different fields:

  • EM validation, cleaning validation.
  • Aseptic Process Validation, Gowning validation.
  • EM monitoring.
  • Sterility tests on final product.
  • Growth promotion tests.
  • EM Trends.

As microbiologist, he/she analyses the impact of the current species on deviations, trends analysis and propose actions to improve the EM/cleaning process.
In order to fulfill his/her role, the Microbiology QC Supervisor:

  • Supervises a team of different experts, and QC support.
  • Takes part to internal and/or external audits, if necessary.
  • Follows regulatory updates.

Among the activities of the current clinical facility, the current challenges are:

  • EM Samples management: LIMS implementation, then daily management.
  • Set-up of the EM validation, cleaning validation of the future commercial facility.
  • EM samples management: set up of a planning to anticipate workload.

In addition the QC supervisor will support the QC Manager/Director with the general improvement of the quality system linked to EM/cleaning/QC microbio as part of the commercial readiness program.

OBLIGATORY REQUIREMENTS

  • At least Master level in bioengineering, biochemistry, biology, etc.; with a specialisation in microbiology.
  • At least 5 years experience in cGMP and QC or experience in a similar position.

USEFUL REQUIREMENTS

  • Experience in people management is a must.
  • English level : at least B1.
  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and proactive.
  • Teamwork and teaching skills.
  • Good communication skills and cheerful.
  • Strong communication skills and fluent in English and French.

Candidate profile

OBLIGATORY REQUIREMENTS

  • At least Master level in bioengineering, biochemistry, biology, etc.; with a specialisation in microbiology.
  • At least 5 years experience in cGMP and QC or experience in a similar position.

USEFUL REQUIREMENTS

  • Experience in people management is a must.
  • English level : at least B1.
  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and proactive.
  • Teamwork and teaching skills.
  • Good communication skills and cheerful.
  • Strong communication skills and fluent in English and French.
     

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.
  • A company car with fuel card.
     

Contact Details

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