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Principal Scientist (d/f/m)

Sandoz Österreich

  • Kundl
  • Feste Anstellung
  • Teilzeit, Vollzeit
  • Homeoffice möglich
  • vor Ort
  • Erfahren (2-5 Jahre)
  • Österreich
  • Gehalt anzeigen
  • Erschienen vor 1 Jahr

Leer

Deine Aufgaben

  • You will lead and coordinate pre-formulation, formulation and process development tasks and represent pharmaceutical development in the project team of assigned projects.
  • You are accountable for managing all pharmaceutical development related activities of Drug Product development incl. pre-formulation, Quality by Design formulation and process development, technology transfers.
  • Design, plan, perform and documentation as well as statistical analysis and interpretation of scientific experiments to drive development of final drug product and manufacturing process for solid and liquid dosage forms applying QbD principles with special focus on rigorous DoE
  • You will need to communicate effectively across organizational interfaces i.e. project-/program management, line functions etc.
  • You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
  • You are responsible for high quality documentation for regulatory submissions and you will interact with authorities, act as technical expert in audits, inspections etc.

Dein Profil

  • You will lead and coordinate pre-formulation, formulation and process development tasks and represent pharmaceutical development in the project team of assigned projects.
  • You are accountable for managing all pharmaceutical development related activities of Drug Product development incl. pre-formulation, Quality by Design formulation and process development, technology transfers.
  • Design, plan, perform and documentation as well as statistical analysis and interpretation of scientific experiments to drive development of final drug product and manufacturing process for solid and liquid dosage forms applying QbD principles with special focus on rigorous DoE
  • You will need to communicate effectively across organizational interfaces i.e. project-/program management, line functions etc.
  • You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
  • You are responsible for high quality documentation for regulatory submissions and you will interact with authorities, act as technical expert in audits, inspections etc.
  • 3-5 years of hands-on industry experience in formulation, preformulation, deformulation and manufacturing process development
  • Proficient in using statistical tools like Minitab, Design Expert etc.
  • Excellent understanding of regulatory expectations and requirements including EMA, US FDA, ANVISA, PMDA
  • Expert understanding of Data Integrity, cGMP, ICH guidelines and regulatory requirements
  • Experience working in interdisciplinary teams with excellent theoretical and scientific knowledge of product development
  • Proven track record of creativity, problem solving and productivity
  • Proficient scientific/technical writing skills
  • Languages: Fluent in English (oral and written), basic German skills are an advantage

Deine Benefits:

  • In addition to a market-competitive base salary, we offer an attractive incentive program
  • a modern company pension scheme
  • childcare facilities
  • learning and development options
  • worldwide career opportunities
  • support for flexible and remote working where possible
  • an agile and collegiate environment with impactful, flexible-hybrid careers
  • personal growth is encouraged
  • diversity is welcomed

Weitere Informationen

Bevorzugte Sprachen:

  • Deutsch

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Ansprechperson

Sandoz Österreich

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Informiere dich jetzt über unseren umfassenden und kostenlosen Bewerbungsservice. Erfahre, wie wir dich effektiv und direkt zu deinem Traumjob führen können!

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