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Project Manager LC-MS Bioanalysis (m/f/d)

  • PhD / post-doc in life sciences (e.g. food chemistry, chemistry, pharmacy) or equivalent
  • Hands-on experience in modern bioanalytical techniques with LC-MS/MS
  • Expertise in relevant analytical software (Analyst, Excalibur or MassLynx) and LIM-systems is required
  • Experience in regulated quality management systems such as GLP/GMP
  • Plan, conduct, evaluate, and report bioanalytical projects in assuming the role as Principal Investigator or Responsible Bioanalyst
  • Assume responsibilities as a Principal Investigator according to the principles of Good Laboratory Practice (GLP)
  • Author, edit, and review bioanalytical protocols and reports
  • Contribute to creation of clinical laboratory manuals
  • Supervise the development and validation of bioanalytical methods for quantification for small molecule drugs according to applicable guidelines and internal procedures via LC-MS/MS
  • Supervise the conduct of routine bioanalytical projects (as part of these projects, review and approve analytical runs, discuss and evaluate analytical results internally and with clients and take ownership of the quality and integrity of the reported data)
  • Discuss new project opportunities and consult clients in order to develop optimal project designs in association with business development
  • Review service estimates in knowledge of (particularly) clinical study designs and translate those in adequate bioanalytical protocols
  • Communicate results and observations in projects to clients on a daily basis
  • Communicate relevant project details to laboratory operations proactively in order to ensure smooth business operations
  • Represent bioanalytical projects during client audits and health authority inspections in association with Quality Assurance

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89231 Neu-Ulm