Director of Physicochemical Analytics Biosimilars

  • Fresenius Kabi
  • Germany
  • Jun 09, 2018
Full time Business Development Sales

5 Jobs

Job Description:

Main tasks:

  • Manage physio-chemical lab operations and strategy
  • Create a protein chemistry lab unit dedicated to biosimilars development
  • Oversee protein chemistry labs developing and running characterization methods, including among others mass spectrometry, electrophoresis and chromatography
  • Oversee high throughput analytical assays for clone development and bioprocess development
  • Provide strategic direction to guide Development Teams towards physicochemical analytical packages
  • Propose and implement analytical outsourcing strategy, balancing opportunities and risks associated with method qualification, validation, tech transfer, and performance monitoring
  • Technical oversight of work done in collaboration with CROs and CMOs
  • Review, edit, and approve internal reports, quality documents, regulatory submissions, and external presentations and manuscripts
  • Manage performance and development of personnel (~20 employees) to ensure achievement of organizational and department goals as well as motivation for high productivity
  • Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget

Your profile:

  • Advanced scientific degree in analytical biochemistry or equivalent studies
  • Several years' relevant experience in the pharmaceutical or biotech industry
  • Successful track record in leading protein/mAb analytics
  • Proven ability to interact with CRO/CMOs and external vendors and to ensure successful tech transfers
  • Management and leadership experience as well as an entrepreneurial way of thinking
  • Ability to ensure and maintain a creative and highly motivating working atmosphere
  • Results orientation and strong strategic thinking
  • Excellent communication, presentation, and interpersonal skills
  • Fluency in English; French or German would be assets

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