Freiberuflicher wissenschaftlicher Berater für die Einführung und Erprobung analytischer Methoden

Role Overview

We are seeking an experienced scientist to support analytical method implementation, optimization, and routine testing within the Analytical Development laboratory. The role will contribute to Drug Substance process optimization activities, with a strong focus on hands-on laboratory execution, data generation, and scientific reporting.

The successful candidate will independently implement analytical methods, perform feasibility testing, troubleshoot analytical challenges, and ensure high-quality documentation in compliance with regulatory expectations.

Engagement Details

• Location: On-site in Vienna (full laboratory presence required)
• Workload: Full-time
• Duration: Eight months, with potential extension based on project requirements
• Start: July/Aug
• End: March 2027

Key Responsibilities

• Independently implement, optimize, and execute analytical methods in the AD laboratory to support process development activities.
• Perform routine and feasibility testing using techniques such as:
  • HPLC / RP-HPLC/ SEC-HPLC
  • ELISA
  • SDS-PAGE
  • Additional protein characterization methods
• Analyze, interpret, and document experimental results in a scientifically sound and traceable manner.
• Troubleshoot analytical methods and resolve technical issues efficiently.
• Ensure proper documentation in line with GMP-like expectations and internal standards.
• Plan and prioritize laboratory activities, including scheduling experiments to meet project timelines.
• Coordinate ordering and availability of required materials, reagents, and consumables.
• Ensure timely turnaround of analytical results to support process optimization decisions.
• Contribute to method performance evaluation in line with ICH Q2(R2) principles.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Protein Chemistry, or a related scientific discipline.
• Extensive hands-on laboratory experience in analytical characterization of biologics.
• Proven experience working with protein molecules, preferably immunoglobulins or complex biological matrices (strong advantage).
• Solid understanding of chromatographic and ligand-binding assay techniques (HPLC, SEC-HPLC, ELISA).
• Experience in protein characterization, including aggregation and stability-related assessments.
• Strong knowledge of analytical method performance evaluation and lifecycle concepts (ICH Q2(R2)).
• Demonstrated ability to work independently in a laboratory setting with minimal supervision.
• Strong organizational skills, with the ability to manage priorities, timelines, and deliverables.
• High attention to detail and commitment to high-quality scientific documentation.