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AOP Health

(Senior) Analytical Lead, Process Science

Remote • Vienna, AUT • Unknown • €50–0k / год
Зарплата
€50–0k / год
Опубликовано
16 мин назад
Описание

_We are looking for a (Senior) Analytical Lead, Process Science to provide scientific and technical leadership for complex analytical programs across the product lifecycle. As a key expert within Process Science, you will shape robust analytical strategies, support product development and regulatory submissions, and help ensure reliable clinical and commercial manufacturing. The role combines deep analytical expertise with cross-functional leadership, continuous improvement, and close collaboration across Technical Development and the wider organization._

What Your Day To Day Will Look Like

  • Develop, validate, and implement robust, phase-appropriate analytical methods for intermediates, drug substances, and drug products, including HPLC, GC, MS, and UV methods.
  • Lead the strategy, planning, and execution of complex analytical development and testing programs, including photostability, development stability, in-use stability, E&L studies and compatibility studies.
  • Review and approve analytical validation protocols and reports, SOPs, technical summaries, and other analytical documentation in line with cGMP and applicable ICH, FDA, and EMA requirements.
  • Interpret development and stability data together with Drug Substance and Drug Product Leads and support th...

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