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Production Cell Culture Expert (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

Expert’s responsibilities need to be adapted according to the development phase of the project from early process development, technical transfer or GMP production. The supervisor could delegate activities to the Expert. The below list is not exhaustive.

General

  • 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.
  • Deals with technology, productions and team management.
  • Generates and ensures finalization documentation (procedures/instructions/forms/protocols) to perform specific production, or generic documentation which could be eventually approved by Supervisor and relevant stakeholder prior to production start.
  • Follow and compiles KPIs of his/her team and feed continuous improvement of the production team;
  • Generates and/or ensures finalization and/or approves of all GMP documentation related to performed production for final approval by hierarchy/certified reviewer.
  • Upon specific request will represent the project he/she manages to internal/external meetings.

Quality

  • For his/her direct responsibility, ensures cGMP implementation through MTC’s quality system and feeds continuous quality improvement.
  • Ensures his/her team is adequately staffed, trained, equipped to execute required work.
  • Takes a special care to continuously train colleagues working in aseptic environment and manages all A/B area monitoring.
  • Support to change control preparation and derogation.
  • Finalizes Deviations and CAPA for hierarchy approval. When transversal actions to close Deviations or CAPA are identified, the Expert is able to evaluate impacts across MTC on top of its own project.
  • Generate product investigations related to OOS opened by QC.
  • Involved in preparation and execution of any audits/inspection.

People management

  • Lead a team of maximum 6 Cell Culture Specialists.
  • Ensure individual development plan of his/her team member is in place and followed.
  • Is responsible of the generic training matrix of his/her team under his/her responsibility.
  • Could delegate activities to Specialist.
  • Perform, with adequate functional Expert, new comer/yearly evaluations.

Candidate profile

OBLIGATORY REQUIREMENTS

  • Work in commercial readiness.
  • Good knowledge of production in a GMP/commercial context with, if possible, a background in a development/industrialization context.
  • Very good writing skills in French and English.
  • Ability to benchmark with people who have process knowledge

USEFUL REQUIREMENTS

  • Organization skills, multitasking.
  • Quality minded, autonomous, rigorous, attentive to details, persevering and pro-active.
  • Teamwork and teaching skills.
  • Good communicator skills and cheerful.
  • Strong communication skills.
  • Fluency in French and English.
  • Respect the targets.
  • Have already managed a team of 5-6 people.

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