GMP Production Officer (F/H)
XPress Biologics is looking for a GMP Production Officer (F/H) based in Herstal. The GMP Production Officer will be responsible for providing documents and data which are necessary to plan and run production requested by the Manager Production Site and the Team Lead Production. The goal is to bring transparency into production processes and to give guidance to production leaders.
Grow with us - Your Responsibilities:
- Follow-up and supervision of GMP sponsored projects according to the specifications and schedule described in the quotations:
- Process Transfer & Scale Up
- Planning of manufacturing steps and writing of manufacturing documents
- Take an active part in clean room activities, with specific supervision of GMP productions / manufacturing performed by lab technicians:
- Buffers and media preparation and inter-campaign activities (CIP, line clearance, environmental controls …),
- Cell banking
- Fermentation, cell lysis and extraction methods,
- Purification by chromatography and tangential flow filtrations,
- Product formulation, final filtration, storage and shipping.
- Compilation and review of executed Batch Records,
- Participation in the GMP storage management and ordering of raw materials, reagents, disposables, and follow-up for customers billing operations.
- Ensure continuous improvement and participation to Quality Management System activities such as:
- Participation to audits,
- Writing of Standard Operating Procedure,
- Deviation, risk analysis, root cause investigation, change control, CAPA follow up,
- Internal project.
- Communicates with project coordinator & sponsor.
- Understands and follows methods for process qualification and validation.
- Critically analyzes complex data, interprets, and integrates experimental result.
- Collaborates with other members of the team, or department, to develop processes and manufacturing systems.
What will convince us:
- Bachelor’s or master’s degree (biology, biochemistry, biotechnology, bioengineering…) with at least 5 years’ experience in a GMP activity,
- Significant expertise related to bioprocess development (molecular biology, fermentation, purification, quality controls, plasmid production and characterization),
- Good project, people supervision and communication skills,
- Dynamic, determined and solution-oriented,
- Autonomy, ability to solve problems independently in a changing environment, to manage several tasks in parallel and to interact with other departments (team spirit),
- Good verbal and written communication in English.
- Proven software skills, e.g.MS Office