Senior Analytical Lead — Process Science & Innovation

AOP Health Group

Wien

On-site

EUR 45,000 - 55,000

Full time

10 days ago
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Benefits offered by this job

Open corporate culture
Career development
Flat hierarchies
Bonus
Competitive salary package

Job summary

AOP Health Group in Vienna, Austria seeks a (Senior) Analytical Lead, Process Science to provide scientific leadership for complex analytical programs across the product lifecycle. You will shape analytical strategies, support development and regulatory submissions, and collaborate across Technical Development and the wider organization.

You will lead method development (HPLC, GC, MS, UV), drive stability studies, review validation documents, mentor the team, and contribute to budget planning.

Qualifications

  • PhD or Master's in chemistry, biotechnology, or process engineering.
  • 10+ years in analytical development and validation for small molecules or biologics.
  • Deep CMC expertise with broader regulatory awareness (EMA/FDA/ICH).
  • Experience with regulatory submissions and handling investigations.

Responsibilities

  • Develop, validate, and implement methods (HPLC, GC, MS, UV) for intermediates, substances, and products.
  • Lead analytical development programs, including stability and E&L studies.
  • Review and approve validation protocols, SOPs, and technical reports per cGMP and regulatory requirements.
  • Interpret data with Drug Substance/Product leads and support specifications.
  • Lead impurity assessments and provide guidance on analytical issues.
  • Collaborate with PM, MSAT, External Manufacturing, and other stakeholders.
  • Represent Process Science in matrix teams and communicate risks and solutions.
  • Support regulatory submissions with analytical data and justifications.
  • Plan and monitor budgets; identify cost and risk reductions.
  • Mentor Analytical Leads and support onboarding and development.

Skills

Analytical leadership
Cross-functional collaboration
Strategic thinking
Project management
Problem solving
Communication skills
English proficiency

Education

PhD or MSc in chemistry/biotechnology/process engineering

Tools

HPLC
GC
MS
UV methods

Job description

AOP Health Group in Vienna, Austria seeks a (Senior) Analytical Lead, Process Science to provide scientific leadership for complex analytical programs across the product lifecycle. You will shape analytical strategies, support development and regulatory submissions, and collaborate across Technical Development and the wider organization.

You will lead method development (HPLC, GC, MS, UV), drive stability studies, review validation documents, mentor the team, and contribute to budget planning.

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