Laboratory Expert Mass Spectrometry

**Laboratory Expert Mass Spectrometry - HPLC-DAD/MS / TOC and ELISA Analysis / GMP/ Agile / On-call service / German** **Project / Role**: For our client, a large pharmaceutical company based in Basel, we are looking for Laboratory Expert Mass Spectrometry. **Background**: The Center of Excellence Cleaning Validation is responsible for scientifically proving that the cleaning process of production equipment that comes into contact with products can remove all residues to ensure that no cross-contamination occurs. Validation is based on toxicological data, sampling and analysis of samples in our laboratories using e.g. HPLC, ELISA, TOC and MS techniques. The trace analytics used are both developed and validated in-house. Our customers include all value streams in Kaiseraugst, Basel Biotech and parts of the IMP area. In the Competence Center Cleaning Validation you have numerous opportunities for further training, as we have both a close connection to pharmaceutical production and are a competence center for trace analytics. Our polyvalent work and further development is what sets us apart. As a lab expert, your focus area in Kaiseraugst will be the development and validation of HPLC methods in the trace range. Even if your focus area is in the HPLC area, constant exchange, collaboration and cooperation with all other methods (HPLC-MS, HPLC-DAD, ELISA, TOC) are also part of your tasks. On-call duty in Basel is also part of your duties. An interest in production facilities and in further development towards MSAT activities for cleaning validation is preferred. We will then discuss the development opportunities in an interview. **Tasks & responsibilities**: - (Further) development of analytical test methods with particular attention to the manufacturing process and the intended use of the product - Efficient, professional and timely execution of the analyses carried out in the laboratory (HPLC-DAD/MS, TOC, BCA, ELISA) in accordance with "internal regulations" and their documentation in accordance with the current guidelines of good manufacturing practice - Validation of analytical methods in accordance with the current guidelines of good manufacturing practice (cGMP) - Documentation of the analyses carried out in accordance with the current guidelines of good manufacturing practice (cGMP) - Summary of partial results for overall analyses and correct reporting on analysis reports (e.g. validation sheets) - Support of analytical devices including implementation or organization of functional tests, qualifications and maintenance in accordance with the device database **Must Haves**: - Completed degree in the field of life sciences, such as analytical chemistry or comparable with at least two years of practical professional experience in a laboratory environment - OR Completed vocational training in the laboratory area with many years of professional experience in the described area - Min. initial experience in the field of HPLC-MS - Experience in carrying out method development and validation - Practical professional experience in carrying out TOC and ELISA analysis is desirable - Min. 2 years of professional experience in a GMP regulated work environment - Experience in interface communication - Interest in analytics - Willingness to constantly develop further and take on new tasks - A high level of teamwork - Agile and creative thinking - Flexibility, agility and the will to implement a lean culture - Fluent German skills **Reference no.: 924058SDA** **Role** : Laboratory Expert Mass Spectrometry **Industry** : Pharma **Location** : Kaiseraugst **Workload** : 100% **On-call duty** : approx. 1 weekend in 2 months **Start** : ASAP **Duration** : 12++ **Job Type**: 100% Work Location: On the road