Allemagne 01.10.2021

Lab Head (m/f/d)

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Scandinavia and Czech Republic.

We are currently hiring a Lab Head in Frankfurt.

Your responsibilities:

  •  Providing scientific input, leading and conducting analytical studies in the analytical testing of intermediates and APIs, including mass spectrometric characterization of by-product profiles and/or of nitrosamines in drug substances and drug products by LC/MS or other appropriate techniques
  • Participating in analytical studies for candidate profiling, stability studies and, in the context of formulation development, also for new drug formats, as well as in the field of testing for mutagenic impurities
  • Participating in the cGMP-compliant qualification of analytical instruments
  • Preparing test documents in compliance with cGMP
  • Conducting cGMP compliant studies including preparation of quality related documents
  • Collaborating in the preparation of regulatory authority-relevant documentation
  • Presenting the analytical investigations e.g., in project teams, at other departments, sites, external analytical service providers and cooperation partners as well as during internal audits, inspections and regulatory inquiries
  • Participating in guiding, motivating, and developing technical staff in accordance with the company's management principles
  • Leading an analytical laboratory with 2 technical co-workers within a group of 3 laboratories of the group

 

Requirements

Profile:

  • Comprehensive practical experience in mass spectrometry and in the coupling of modern analytical separation methods such as HPLC or GC with mass spectrometry
  • Practical experience in analytics with focus on method development and validation of chromatographic separation procedures
  • Highly motivated individual with the ability to work independently and self-reliant as well as on a cross-functional and cross-site teams
  • Strong organizational skills and determination
  • Ability to present complex issues in a precise and comprehensible manner
  • Very good command of written and spoken English and German
  • Structured and solution-oriented way of working and thinking
  • Very good communication skills (e.g., as regular communication between development, analytical, quality departments as well as clinical manufacturing are required daily)
  • Sense for lean ways of working and motivation to build-up efficient processes
  • Able to lead and influence networks, teams, and experts
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