Cell Culture Expert
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 Good Manufacturing Practice (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.
- May be involved in all stages of production process maturity (from development or acquisition to continuous commercial Good Manufacturing Practice (GMP) production) and follow up of closed projects.
- Manage and master critical parameters of production process.
- Must deal with equipment and technology.
- Responsible for management of direct reports.
- Create, finalize and/or approve instructions/forms/protocols related to specific production or generic documentation which could be approved by a Supervisor and relevant stakeholder prior to production start.
- Compile key performance indicators (KPIs) of your team and encourage continuous improvement.
- Respect environmental health and safety (EHS) rules in working area.
- Plan, coordinate and perform daily production.
- Organize production campaigns.
- Must be highly qualified/trained to work in A/B environment and able to train colleagues.
- Must dedicate appropriate time in production area to ensure all duties to produce are met and perform production activities to support Cell Culture Specialists.
- Create, finalize and/or approve GMP documentation related to performed production for final approval by hierarchy/certified reviewer.
- Upon request, must represent the project you manage at internal/external meetings.
- May be responsible for one (1) or several production areas out of dedicated project (daily double checks of area parameters).
- Plan (in partnership with Shared Service Team) and guarantee realization of grades A/B major cleaning (monthly, quarterly, yearly).
- Coordinate (in partnership with Shared Service Team/Technical Service) vaporized hydrogen peroxide (VHP) realization.
- Ensure current Good Manufacturing Practice (cGMP) implementation through Masthercell’s quality system and encourage continuous quality improvement.
- Continuously train direct reports working in aseptic environment and manage all A/B area monitoring.
- Finalize Deviations and Curative and Preventive Actions (CAPA) for hierarchy approval.
- Create product investigations related to out of specifications (OOS) opened by Quality Control (QC).
- Prepare and execute audits/inspections.
- Expert in Cell Culture and GMP Aseptic Environment.
- Cell Therapy Specific Context.
- Customer Oriented.
- Continuous Improvement Driven.
- Demonstrated Team Management Capabilities.
- Cross-Functional Team Spirit.
- Well Organized.
- Able to Multi-Task.
- Good Communicator.
- Master’s Degree in Biology, Pharmacy, Clinical Chemistry, Bioengineering or relevant experience in the fields of Biotech/Pharma/Cell Therapy.
- Minimum of two (2) years confirmed experience in GMP environment or equivalent experience in University non-GMP CORE training or training facility.
- Minimum of two (2) years confirmed experience in cell culture production and/or human cells cultivation.
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