Method Validation QC Expert

As Method Validation QC Expert, you ensure the scientific and regulatory robustness of all analytical validation activities at simAbs. You design, execute, and oversee assay validation plans to guarantee data integrity, compliance, and reliability — essential foundations for our biologics development and manufacturing programs. Your expertise also supports analytical requirements specific to biosimilars, including comparability and characterization studies.

Responsibilities
• Define and execute method validation strategies in line with ICH and GMP guidelines.
• Draft validation protocols and reports, review raw data, and ensure data integrity.
• Coordinate with QC, Analytical Development, and external laboratories to ensure consistent validation practices.
• Troubleshoot technical challenges and provide expert guidance to project teams.
• Support process changes with comparability assessments.
• Manage deviations, CAPAs, and improvement initiatives related to analytical performance.
• Communicate validation progress and findings to stakeholders clearly and proactively.

Qualifications
• Master’s or PhD in Life Sciences, Analytical Chemistry, or Biotechnology.
• Proven experience in analytical method validation in a regulated biopharma or biotech setting.
• Strong understanding of GMP, ICH Q2(R2), and analytical quality systems.
• Strong knowledge of biosimilar analytical requirements and hands-on experience with validation or comparability 
assessments for biosimilars (highly valued).

Competences
• Analytical and detail-oriented mindset.
• Expertise in statistical validation principles and data interpretation.
• Excellent documentation and reporting skills.
• Capable of managing multiple validation projects simultaneously.
• Motivated by science, quality, and innovation in a collaborative start-up environment.