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Group Head Bioanalysis (m/f)


  • Lead a LC/MS bioanalytical group for quantification of small molecules compounds (NCEs) with assigned heads of laboratory and laboratory technicians
  • Manage and coordinate work and work packages within the group in order to ensure optimal employment of resources. Ensure timely delivery of data and reports
  • Peer review plans, data evaluations and reports in drug discovery and development to ensure scientific excellence and adherence to SOPs and client's requests
  • Develop and validate bioanalytical methods for quantification of new molecular entities according to applicable guidelines and internal procedures via LC-MS/MS together with the group
  • When required, assume responsibilities as a Study Director / Principal Investigator according to the principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  • When required, perform pharmacokinetic/toxicokinetic data evaluation applying state-of-the-art software (Phoenix WinNonlin) and write scientific assessments thereof
  • 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
  • Validation of computerized systems in accordance with applicable guidelines (OECD 17) and internal procedures and assume responsibilities as a system owner
  • Assume responsibility (and accountability as per delegation) for and enforce adherence to safety measures in the laboratory
  • PhD in life sciences (e.g. chemistry, food chemistry, pharmacy) or equivalent
  • At least 5 years experience in LC/MS bioanalysis in GxP regulated environment in the pharmaceutical industry or at CROs
  • Hands on work experience and troubleshooting skills in modern LC-MS/MS bioanalysis
  • Expertise in relevant analytical software (Analyst, Excalibur or MassLynx) is required, experience in LIMS (Watson) would be an advantage
  • Professional experience in pharmacokinetic data evaluation including relevant software is required
  • Experience in regulated environment such as GLP and GCP
  • Good understanding of R&D-related sciences/practices and knowledge of international regulatory principles and guidelines from health authorities (e.g., EMA, FDA, ICH)


—> Job description


Employer:
NUVISAN Gruppe
Location:
Grafing bei M√ľnchen

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