Production Supervisor, Cell Therapy
MaSTherCell is a dynamic 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 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.
The Production Supervisor, Cell Therapy is responsible, coordinates and is actively involved in Shared Service activities as follows:
- Ensure training plan/matrix for Production staff is adequate, effective and updated.
- Ensure completion of all training of Production staff.
- Ensure efficient training tools and adequate trainings are delivered.
- Implement the “Train the Trainer” system.
- Ensure gowning qualification and requalification for grades B/A personnel.
- Ensure generic Aseptic Process Simulation (APS) for grade A personnel is completed.
- Ensure the implementation and follow-up of a training record system.
- Create a training key performance indicator (KPI).
Logistic and Environmental Monitoring
- Ensure environmental monitoring (EM) and cleaning conformities, and respect of frequencies for all grades.
- Ensure grades C/D Environmental Deviation (Dev) and Curative and Preventive Actions (CAPA) are well managed and followed.
- Ensure to provide sufficient support to production for realization of grades B/A major cleaning and monitoring (monthly, quarterly, yearly).
- Ensure production daily checks of environmental monitoring system (EMS) reports.
- Ensure that EM trends are analyzed for production matters and that actions are taken for parts under your scope.
- Ensure rooms & projects’ inter-campaigns are realized in time with the scheduled needs of production and that documentation is well completed.
- Ensure Vaporized Hydrogen Peroxide (VHP) is realized and reports are reviewed.
- Ensure consumables are ordered for production, in addition to all other generic furniture.
- Ensure effective material transfer in classified rooms (grades D or C) and generic consumables stock level in common rooms.
- Ensure good interactions with quality control (QC) regarding EM and with technical service (TS) concerning logistics.
Facilities and Equipment
- Act as the interface between Production and Technical Service (TS)
- Guarantee production equipment management in partnership with TS and Production.
- Approves user requirement specification (URS) for generic equipment.
- Ensure equipment (re)qualification protocol writing under Shared Service responsibility.
- Responsible for or consulted about equipment ordering and selection.
- Ensure adequate qualification of equipment for Shared Service responsibility.
- Follow-up of curative maintenance on defective equipment.
- Responsible for production equipment logbook management.
- Responsible for furniture and utilities management in clean rooms.
- Ensure modification and improvement of current areas, and requalification if needed.
- Ensure production input for new facilities design is well implemented and new facilities qualification.
- Ensure URS writing for transversal and generic processes (as electronic samples storage management) and selection of these systems.
- Ensure transversal and generic process is validated (as Vaporized Hydrogen Peroxide (VHP)).
- Ensure Liquid Nitrogen (LN2) and -80°C freezer occupation, inventory and cleaning status management.
- Ensure efficient transversal documents are available and followed, with the support of adequate tools and training.
- Ensure current Good Manufacturing Practice (cGMP) implementation through Mastercell’s quality system.
- Ensure continuous improvement by dedicating appropriate time in Production area to ensure all duties to produce in accordance to quality system and defined plan are implemented.
- Create, finalize and/or approve generic and transversal documentation as policies/procedures/instructions/forms/protocols which could be eventually approved by any relevant stakeholder.
- Create and track KPIs to continuously feed quality and efficacy improvement. Ensure a system is in place to follow trends and anticipate proactive actions.
- Coordinate preparation and execution of any audits/inspections.
- Establishes in collaboration with QA L1 audit universe, planning for prod and performs some audits.
- Ensure execution and follow-up of any/all Deviation (Dev) and Curative and Preventive Actions (CAPA).
- Responsible for GMP watchfulness.
- Effective Communicator.
- Sense of Ethics.
- Demonstrated Leadership.
- Team Management.
- Cross-Functional Team Spirit.
- Team Development.
- Technical Know How.
- Quality Minded.
- Customer Oriented.
- Master’s Degree in Biology, Chemistry, Bioengineering, Pharmacy or relevant experience in the fields of Biotech/Pharma/Cell Therapy.
- Minimum of five (5) years’ experience in Good Manufacturing Practice (GMP) environment, aseptic production, team and/or project management.
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