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AOAOP Health

(Senior) Analytical Lead, Process Science (m/w/x) Wien

ab 49.840 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung

Analytical method development and validation for rare disease therapies. 10+ years analytical development experience required. Home office, bonus, and flexible hours.

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Anforderungen

  • Higher degree (PhD or Master’s) in technical/scientific discipline
  • 10+ years professional experience in analytical development/validation
  • Deep expertise in at least one CMC area
  • Strong working knowledge of broader CMC environment
  • In-depth knowledge of analytical instruments/techniques
  • Experience in chromatography and mass spectrometry
  • Experience in stability studies and impurity profiling
  • Familiarity with EMA, FDA, ICH, WHO, global regulatory requirements
  • Experience with regulatory submissions or health authorities (advantageous)
  • Experience with investigations, OOS, deviations, CAPAs (beneficial)
  • Ability to lead without hierarchical authority
  • Work effectively in international, cross-functional matrix teams
  • Strong strategic thinking capabilities
  • Strong execution capabilities
  • Strong project management capabilities
  • Strong analytical capabilities
  • Strong problem-solving capabilities
  • Customer-oriented mindset
  • Collaborative mindset
  • Ability to build strong relationships with stakeholders
  • Excellent verbal communication skills in English
  • Excellent presentation skills in English
  • Excellent written communication skills in English
  • Basic German skills (beneficial)

Aufgaben

  • Provide scientific and technical leadership for analytical programs
  • Shape robust analytical strategies
  • Support product development and regulatory submissions
  • Ensure reliable clinical and commercial manufacturing
  • Develop, validate, and implement analytical methods
  • Lead analytical development and testing programs
  • Review and approve analytical documentation
  • Interpret development and stability data
  • Support the development of specifications
  • Lead impurity assessments
  • Provide technical guidance for analytical issues
  • Collaborate with stakeholders to support product development
  • Represent Process Science in Technical Development teams
  • Communicate risks, critical topics, and solutions
  • Support regulatory submissions with analytical data
  • Provide technical input for due diligence
  • Plan and monitor budgets for assigned activities
  • Identify opportunities for cost and risk reduction
  • Drive continuous improvement in analytical technology and processes
  • Promote knowledge sharing and scientific learning
  • Mentor Process Science Analytical Leads
  • Support team member onboarding, training, and development

Berufserfahrung

10 Jahre

Ausbildung

Doktor / Ph.D.

Sprachen

Englisch – verhandlungssicher
Deutsch – Grundkenntnisse

Tools & Technologien

chromatographymass spectrometry

Benefits

Attraktive Vergütung
  • Competitive salary package
Boni & Prämien
  • Bonus
Flexibles Arbeiten
  • Homeoffice
  • Flexible working hours
Moderne Technikausstattung
  • Employee mobile phone
  • Laptop
Weiterbildungsangebote
  • Initial and continuing education
Gratis oder Vergünstigte Mahlzeiten
  • Canteen
Parkplatz & Pendelvorteile
  • Good transport connection
  • Parking spot
Team Events & Ausflüge
  • Employee events
Sonstige Zulagen
  • Meal allowance
Gesundheits- & Fitnessangebote
  • Company doctor
  • Health measures
Mitarbeiterrabatte
  • Employee discount
Firmenwagen
  • Company car

Von Nejo automatisch aufbereitet

Nejo hat diesen Job automatisch von der Website des Unternehmens AOP Health erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

Zur Originalanzeige bei AOP Health

Über das Unternehmen

AO
PharmaceuticalsWien

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.

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