Analytik NEWS
Online Laboratory Magazine
06/26/2022

Head Operations Bioanalytics (m/f/d)

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Minimum requirements:

  • PhD in Natural/Biological Sciences with 10 years + practical experience in bioanalytics and immunology
  • Experience in people and operational management
  • Experience in bioanalytical assay development and validation (PK/PD and immunogenicity)
  • Experience with regulatory agencies/guidelines and industry standards
  • Good understanding of GxP, ISO17025
  • Excellent interpersonal, leadership and teamwork skills
  • German and English fluent in written and spoken

Your key responsibilities:

  • Management and supervision of the bioanalytical operational activities at the site Oberhaching with 5 laboratory teams
  • Ensure timely development and validation of bioanalytical PK, PD and immunogenicity assays as well as analysis of serum samples for the support of preclinical and clinical trials
  • Represent Clinical Bioanalytics for assigned project internally and externally and provide scientific expertise to the bioanalytical testing as well as strategic planning activities.
  • Plan laboratory operation resources according to project priorities
  • Ensure timely preparation of SOPs, analytical plans and reports according to GxP/ISO17025
  • Support and drive bioanalytical laboratory excellence projects
  • Support preparation of scientific documents including registration documents and lead interaction and communication with HA.
  • Ensure compliance with legal (e.g. radiation safety, biological safety, worker safety) and regulatory requirements (GxP, ISO17025)
  • Professional development of associates.
  • Budget planning


» Job description


Employer:
Sandoz GmbH
Location:
82041 Oberhaching
Temporary:
No
Part-time:
No