- Routinely perform analytical testing of IPC/IPM's, 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 review/labelling).
- Be involved in the transfer/co-validation of analytical methods from other laboratories.
- Demonstrate ability to analyse data, with good attention to details.
- Ensure executed batch record review.
- Perform the aliquoting of reference standard samples.
- Record in LIMS and double-check analytical data during the executed batch record review.
- Openly exchange results, observations, and possible improvements.
- Highlight any atypical result or out of specification results according to the established procedures.
- Present/discuss results in project team meetings.
- Contribute to the implementation of new technologies where appropriate.
- Train Production Team (Operators/Technicians) in performing simple in process analytical procedures on the production floor.
- Train/coach newcomers to analytical methods.
- Follow the procedures in place as well as the HSE rules in the laboratory.
- Ensure the maintenance and qualification of some analytical equipment.
- Ensure lab activities are compliant with the GMP procedures (SEM monitoring, audit...)
- Support regulatory submissions, audits and inspections as requested by the business.
- Contribute to the logistics in the lab (reagent ordering, etc.) and keep it tidy and organized (housekeeping, 5S approach).
- Bachelor's degree.
- At least 2 to 3 years of experience in the operation of, and the analysis with the following analytical equipment: HPLC (Empower), required.Spectrophotometer, Electrophoresis, pH-meter, Conductivity-meter, Osmometer, ELISA, qPCR, strong assets.
- Technical knowledge of protein structure and function, and the analytical techniques required to study them.
- Strong laboratory skills, with good attention to details.
- Ability to communicate effectively with very good command in French and good command in English, as the Senior Technician will be liaising with colleagues from UCB sites in Belgium as well as in the UK.
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Senior Technician HPLC - Braine-l'Alleud, België - UCB
Beschrijving
Make your mark for patients
We are looking for a Senior Technician HPLC who is proactive, rigorous and flexible to join us in our In-Process Sampling & Analytics (IPSA) team and more precisely the Analytical Development Sciences for Biologicals Department, based in Braine-l'Alleud , Belgium.
About the role
The Biologics Pilot Plant is manufacturing Bio Drug Substance (DS) for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.
The role consists in operational and analytical support to the Biologics Pilot Plant, with special focus on (but not limited) supporting the sampling and the analytical testing activities of the In-Process samples generated during the GMP production of Drug Substance for clinical trials as well as technical/engineering runs.
All activities are to be delivered to appropriate agreed quality standards and timelines in accordance with the business priorities.
This position requires some flexibility to support punctually critical IPC analysis generated in 14h-22h shift during bank holidays or weekend (6-8 times /year).
What you'll do:
Interested? For this role we're looking for the following education, experience and skills
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
