Expert Extractables & Leachables (E&L)

Project overview

Expert Extractables & Leachables (E&L)

Reference: 662d6fe3-111c-4a64-a661-d032dddb7077

Responsibilities

• Technical support for Extractables & Leachables studies
• Support with planning and study design
• Conducting risk assessments
• Technical review and evaluation of study and analysis results
• Interpretation of identified extractables/leachables and evaluation of results
• Derivation of necessary follow-up measures based on study results
• Review or support with study protocols and final reports
• Consultation on E&L-specific analytical and regulatory issues

Requirements

My advantages:

• Sound experience in the field of Extractables & Leachables
• Experience with E&L studies for pharmaceutical products and their technical evaluation
• Experience with pharmaceutical products or drug-container/device systems
• Very good understanding of analytical methods, especially chromatography/mass spectrometry
• Ability to interpret analytical results and derive follow-up measures
• Experience with container closure systems / product-contacting materials (advantageous)
• Knowledge of relevant regulatory requirements and guidelines (advantageous)
• Experience with method development/validation and stability/impurity assessments (advantageous)
• Exciting role at a renowned life science company

Project details

asap

4 MM++

• Start: ab sofort
• Duration: 4 Monate
• Remote: onsite
• Location: Remote, Deutschland, DE
• Languages: German