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TS- Technical Leader (m/f)

November 22nd 2019

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 onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

Mission Description

In order to fulfill his/her role, the TS - Technical Leader is focused on the following topics :

Technical expertise

  • He/she is the Subject Matter Expert covering technical questions related to his TS project launch activities, by customers or internal teams.

Communication

  • He/she is the interface between the TS department and all other MaSTherCell’s departments and customer for technical aspects related to projects he/she is leading;
  • He/she warns the TS Supervisor / Manager in case of issue;
  • He/she maintains an open and effective communication with all departments;
  • Takes part to audits when necessary.

Planning management

  • He/she manages the action log related to projects he/she is leading and respects the timelines;
  • Organizes and manages regular meetings to ensure the follow-up of all tasks linked to his projet;
  • Ensures respect of KPI.

Documentation

  • Drafts/reviews Masthercell documents related to his/her project(s) (protocols, reports, procedures, forms, instructions, …);
  • Double checks project specific documents filled in by other.

Quality

  • For his/her direct responsibility, he/she ensures cGMP implementation through MTC’s; quality system and feeds continuous quality improvement;
  • He/she documents his/her work according to current procedures and GMP;
  • He/She is involved in preparation and execution of any audits/inspection;
  • Supports change control preparation;
  • He/She initiates and finalizes Deviations (Owner role) and CAPA for hierarchy approval. When transversal (on top of the specific field) actions to close Deviations or CAPA are identified, the expert is able to evaluate impacts across MTC on top of its own responsibility field;

Trends & continuous improvement

  • He/she implements and follows-up Key Performance Indicators. He/she proposes and takes appropriate actions;
  • He/she implement pertinent tools of operational excellence “Lean culture”.

Candidate profile

Qualifications & Experience

  • Master/Engineer in Science, electro-mechanical or equivalent by experience.
  • At least 5 years of experience (in pharmaceutical field is a plus: ie technical support/maintenance/validation/clean room/equipment management).

Skills & Competencies

  • Efficient communicator and willing to bring new challenges
  • Demonstrated leadership and cross functional team spirit
  • Rigorous, conscientious, versatile, open-minded & quality-minded
  • Customer oriented
  • Fluency in French& English
  • Good reading comprehension and writing skills in English. 
  • Computer skills:  Microsoft office, expertise with GMAO tools (gestion de la maintenance assistée par ordinateur), database management tool

Offer

  • Full-time position (40h/week)
  • An Indeterminate contract and a competitive salary with extra-legal benefits
  • The opportunity to take part in a growing dynamic biotech company
  • A human-sized working environment with a convivial atmosphere

 

Contact Details

Click on this link to apply: http://bit.ly/2Hy01rw