Laboratory Analysis entails conducting a wide range of laboratory analyses, within a pharmaceutical manufacturing setting, ensuring accuracy and compliance with current standards and procedures.
Key responsibilities include;
* Performing routine and specialized tests such as HPLC/UPLC analysis on biological molecules, CGE, ELISA, particle analysis, ... according to Standard Operating Procedures (SOPs) and supporting process development work and root cause investigations according to protocols
* Maintaining the laboratory environment, ensuring safety specifications, and overseeing the maintenance and calibration of laboratory equipment required for process development
* Depending on the specific assignment, duties may extend to analytical method validation support, managing and processing samples, handling inventory of reagents and consumables and improvement projects
* The service also requires administrative tasks and ensuring laboratory Key Performance Indicators (KPIs) are met
Qualifications:
* For this service, the ideal resource should possess strong analytical skills, attention to detail, and a results-oriented approach
* Essential qualifications include the ability to strictly follow written and oral instructions, safety procedures, and GLP standards
* Proficiency in laboratory information management systems and other PC software applications like MS Office is crucial
* The ideal service resource must demonstrate strong problem-solving abilities, capable of investigating root causes and developing solutions for issues and deviations
* Excellent interpersonal and communication skills are vital for effective collaboration with internal teams and external stakeholders
* Prior experience as a lab analyst in the biochemical or medical sector, or in Quality Control, is beneficial
* Experience with at least one of the following is a must: UPLC-HPLC (pref. on Empower platform)/capillary gel electrophoresis/ELISA Flexibility in scheduling, potentially including covering inadvertent times may be required
* For senior levels, experience in training and mentoring less experienced team members, and leading new method validation and instrument implementation, is an asset