Job ID: 11837

(Senior) Fellow (m/f/d) Program Management Bioanalytics

The (Senior) Fellow (m/w/d) Program Management Bioanalytics actively drives the bioanalytical and immunogenicity strategy for the biosimilar programs by representing Clinical Bioanalytics in cross-functional global teams, during health authority interactions, in audits and inspections as well as in due diligence activities.

Stellenart.

Project Consulting

Ihre Aufgaben.

  • Provide expert knowledge for bioanalytical methods and data evaluation (PK/PD and immunogenicity) to global program teams as bioanalytical representative and lead the bioanalytical and immunogenicity nonclinical and clinical program strategy throughout different stages in biosimilar development
  • Write excellent scientific reports, briefing books for health authority interactions and registration documents (eCTD modules; Immunogenicity Risk Assessment)
  • Review and interpret results, evaluate data and draw relevant conclusions; perform complex tasks without having established procedures
  • Participate in audits, inspections and due diligence activities where appropriate
  • Independently lead and manage projects and handle several activities at a time
  • Proactively identify potential project hurdles, provide solutions and implement contingency plans
  • Present scientific/strategic topics at conferences and publish internally or externally; may require up to 10% travel

Ihr Anforderungsprofil.

  • Science degree with PhD and a minimum of six years relevant industrial experience, demonstrated experience in working with interdisciplinary teams as recognized expert in the international scientific community with excellent leadership skills
  • Thorough understanding of development activities and strategic thinking
  • Excellent theoretical and scientific knowledge in the relevant area (e.g. large molecule analytics, immunogenicity) as well as scientific project management skills
  • Excellent knowledge on relevant regulatory guidelines and very good understanding of regulatory expectations paired with excellent knowledge and experience with laboratory and/or technical tools
  • Good knowledge of software and computer tools
  • Proficient scientific/technical writing skills
  • Demonstrated successful experience with working in interdisciplinary teams, problem solving and productivity in projects
  • Fluent in English (oral and written)

Vorteile.

  • Flexible Working Hours
  • Further training opportunities
  • Working in an international environment with state of the art processes

Gehalt.

Von: Keine Angabe
Bis: Keine Angabe

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