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22 дня назад

Global Head of Characterization BioAnalytics (Biopharma)

129 040 - 193 560€
Формат работы
onsite
Тип работы
fulltime
Грейд
head
Английский
c1
Страна
Germany
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Global Head of Characterization BioAnalytics (Biopharma): Leading a global organization responsible for analytical characterization of biologic therapies from CMC development through commercialization and transfer to Manufacturing & Supply with an accent on CQA definition, analytical control strategies, and advanced characterization platforms. Focus on building high-performing teams across sites, harmonizing global operations, supporting regulatory submissions, and transferring high-performance analytical methods.

Location: Frankfurt am Main, Germany

Salary: €129,040–€193,560 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.

What you will do

  • Lead a new global organization of BioAnalytics groups across multiple sites and countries.
  • Develop and implement extended characterization strategies for antibodies, nanobodies, multispecifics, and viral and nonviral gene therapy modalities.
  • Define critical quality attributes and connect them to analytical and integrated control strategies.
  • Manage resources, budgets, forecasting, priorities, and deliverables across a complex biologics pipeline.
  • Build teams, develop scientific talent, harmonize processes, and ensure operational and scientific excellence.
  • Advance analytical platforms, support CMC dossiers and global submissions, and transfer high-performance analytical methods to Manufacturing & Supply.

Requirements

  • At least 15 years of industry experience, including at least 5 years leading an analytical characterization function.
  • Extensive experience in extended characterization of large molecules and late-phase development.
  • PhD in Analytical Chemistry, Molecular Biology, or an equivalent qualification.
  • Strong knowledge of CMC for biological drug development, process and formulation development, Quality by Design principles, and ICH guidelines.
  • Experience with global submissions, regulatory agency interactions, analytical project leadership, organizational change, and matrix environments.
  • Fluent English required.

Nice to have

  • Advanced scientific network in academia and industry.
  • Track record of publications and patents.
  • Familiarity with digitalization and the evolution of AI in CMC.

Culture & Benefits

  • Supportive, future-focused environment with opportunities for promotion and international career development.
  • Rewards package and employee benefits based on contribution and impact.
  • Healthcare, prevention, wellness programs, and at least 14 weeks of gender-neutral parental leave.
  • Work at the intersection of drug discovery, AI, data, and digital platforms.
  • Patient insights are incorporated early into drug development and study design.

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