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The Biologics Pilot Plant is manufacturing biological Drug Substance for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.
The mission consists of operational and analytical support to the Biologics Pilot Plant, during routine operations, with special focus on, but not limited to support to the In-Process Controls team through technical and coordination tasks as well as supporting the implementation of improvements to SOPs and process related documents (sampling plans, batch records, check-lists, …)
- Routinely perform analytical testing of IPCs, to ensure a timely monitoring of the GMP and non-GMP process as well as various GMP and Non-GMP process samples for understanding of the manufacturing process and relevant product quality attributes.
- Troubleshoot and solve analytical issues on the techniques run in the laboratory.
- Prepare documentation (procedures, protocols, reports, sampling plans, batch records).
- Be involved in the transfer of analytical methods from other laboratories.
- Demonstrate ability to analyze data, with good attention to details.
- Have an excellent record keeping and documentation.
- Openly exchange results, observations, and possible improvements.
- Present/Discuss results in project team meetings.
- Contribute in the implementation of new technologies where appropriate.
- Train process operators in performing simple in process analytical procedures on the production floor.
- Follow the procedures in place as well as the HSE rules in the laboratory.
- Work according the agreed timelines.
- Highlight any atypical result or out of specification results according to the established procedures.
- Ensure the maintenance and qualification of some analytical equipment.
- Contribute to the logistics in the lab (reagent ordering, etc…)
- Ability to communicate effectively with good French and English (written) skills
- The post holder have technical knowledge of protein structure and function, and the analytical techniques required to study them. Experience in the operation of analysis with the following analytical equipment: ELISA, Electrophoresis, qPCR, microscopy, HPLC, spectrophotometer, pH-meter, conductivity-meter, osmometer.
- Ability to author comprehensive summary.
- Strong laboratory skills and a track record of spending >75% of current and past work function in the laboratory.
- Ability to multi-task and organize and communicate large amounts of data.
- Good Interpersonal skills to communicate and maintain good working.
- Ability to work under pressure in a team environment under deadlines.
We offer you an attractive salary as well as an attractive salary package with possibility of a company car. You'll also work in a dynamic environment with great challenge.