https://www.fradeo.com/fr/candidats/offres-emploi-franco-allemandes/senior-bioanalytical-scientist-department-head
AXEPTA SA
Responsibilities:
- Leading an LC/MS bioanalytical department for quantification of small molecules compounds consisting of operational managers, project managers and analysts.
- Implementing large molecule bioanalytical work using LC/MS instrumentation.
- Managing and coordinating work packages within the group in order to ensure optimal employment of resources and timely delivery of data and reports.
- Peer review plans, data assessments and reports to ensure scientific excellence and adherence to SOPs and client’s requests.
- Drive continuous improvement and excellence strategies for the department.
- Assist and trouble shoot development and validation of bioanalytical methods for quantification of new molecular entities.
- Act as a GLP test site manager according to German Chemicals Act.
- Ensure adequate training of staff in order to further develop capabilities and ameliorate where gaps are identified.
- Evaluate, develop, and implement new technologies, techniques, and skills in accordance with company strategy and follow literature especially in the area of sample preparation, mass spectrometry and laboratory automation.
- Lead validation of computerized systems in accordance with applicable guidelines (OECD 17) and internal procedures and assume responsibilities as a process owner.
Your profile :
- You have a scientific background in Life Sciences (e.g. pharmacy, chemistry, or food chemistry), ideally a PhD
- You also have previous relevant experience as study director/principal investigator in LC/MS bioanalysis in the pharmaceutical industry or at CROs in a GxP regulated environment (at least 10 years)
- Hands-on experiences and troubleshooting skills in modern LC-MS/MS bioanalysis.
- Professional experience in pharmacokinetic data evaluation including relevant software is required.
- Sound understanding of R&D-related sciences/practices and knowledge of international regulatory principles and guidelines from health authorities (e.g., EMA, FDA, ICH).
- With excellent leadership skills and sense of urgency, you are able to create a team spirit, commitment to objectives and clear accountability.
- Fluent in English and German