Analytical Laboratory Assistant m/f
- Michael Page
- Date de publication
Our client is an international bio-pharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and speciality care.
Description du poste :
* Perform post manufacturing stability studies and compatibility studies, generate associated documentation and interpret results.
* Support in documentation review/writing for stability programs (working documents, protocols, reports, presentations ... ).
* Participate in validation work with a sound understanding of method validation procedures. Generate associated data and interpret results.
* Support (design/perform/participate ... , as appropriate) analytical investigations linked to the job purpose, if required.
* Perform QC check of data generated by operators involved in stability testing
* Support operators in results interpretation and continuous improvement in data generation.
* Responsible for the ANA Lab equipment assigned:
* Perform internal routine maintenance and calibration of ANA Lab equipment assigned.
* Act as person of contact for external annual maintenance/troubleshooting/ calibration/IQ-00 (as appropriate) of ANA Lab equipment assigned.
* Manage associated documentation.
* Act as back up responsible for the equipment assigned
* Participate proactively in continuous improvement of Quality system (involvement in current CAPA, promote ideas ... )
* Create and maintain rigorous documentation of data/documentation/work performed.
* Order, record and maintain laboratory supplies.
* Maintain the ANA Lab activities and organisation with the required high level of Quality.
* Participate to the training of new employees/peers when necessary
* Prepare power point slides and give presentations in English at internal meetings
Description du profil :
* Advanced technician's certificate or bachelor's degree in biotechnology, or equivalent is required
* 3 to 5 years plus experience in pharmaceutical/biotech company or equivalent are required
* Good overall knowledge of GMP, understand current quality system and H&S procedures and apply them in the daily work is required
* Fluent in French, technical level in spoken and written English are required
* Software: Microsoft Office, Empower, Gen5, iCE software, Karat32, PharmSpec, SoloVPE, Oceasoft, Graphpad
* Technical skills:
~ HPLC/UPLC: size exclUSion, reverse phase/hydrophobic interactions, ionexchange, protein A (if required), boronate (if required)~ Electrophoresis: 50S-PAGE (including densitometry), lEF, capillary (iclEF, ce-50S)~ Spectrophotometry~ ELISA-based methods: LAL, HCP, Prot A, qPCR, Proximity Ligation Assay, if required~ European Pharmacopoeia methods: Sub-visible particles counting, pH measurement, visual assessment (visible particles, colour, opalescence of solutions)