Senior Analytical Lead, Process Science - Drive Impact

AOP Health; Wien; On-site; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Open corporate culture

Personal and professional development

Excellent career opportunities

Competitive salary package + bonus

Job summary

AOP Health in Vienna seeks a Senior Analytical Lead, Process Science to provide scientific and technical leadership for complex analytical programs across the product lifecycle. You will shape robust analytical strategies, support development and regulatory submissions, and help ensure reliable clinical and commercial manufacturing.

This role combines deep analytical expertise with cross‑functional collaboration across Technical Development and the wider organization, driving continuous

Qualifications

• PhD or MSc in chemistry/biotech or process engineering.
• 10+ years in analytical development and validation of small molecules and/or biologics.
• Deep CMC expertise with broad regulatory knowledge.
• Strong chromatography and MS knowledge; stability and impurity profiling.
• Familiar with EMA, FDA, ICH, WHO and global regs; regulatory submission experience advantageous.
• Experience with investigations, OOS results, deviations, and CAPAs.
• Proven ability to lead matrix teams internationally.
• Strong strategic thinking, execution, and communication in English; German helpful.

Responsibilities

• Develop, validate, and implement robust analytical methods for intermediates, drug substances, and drug products.
• Lead analytical development programs including stability, photostability, and E&L studies.
• Review validation protocols, reports, SOPs, and technical summaries per cGMP and regulatory requirements.
• Interpret data with leads to support development of specifications.
• Lead impurity assessments including nitrosamines and elemental impurities.
• Collaborate with PM, MSAT, External Manufacturing, and Technical Writing for product development.
• 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 reduction opportunities.
• Drive continuous improvement in analytical technology and AOP processes.
• Mentor Analytical Leads and support onboarding and development.

Skills

Analytical leadership

Cross-functional leadership

Strategic thinking

Project management

Problem solving

English communication

German language

Education

PhD or MSc in chemistry/biotech/process engineering

Tools

HPLC

GC

Mass spectrometry

UV spectroscopy

Job description

AOP Health in Vienna seeks a Senior Analytical Lead, Process Science to provide scientific and technical leadership for complex analytical programs across the product lifecycle. You will shape robust analytical strategies, support development and regulatory submissions, and help ensure reliable clinical and commercial manufacturing.

This role combines deep analytical expertise with cross‑functional collaboration across Technical Development and the wider organization, driving continuous