Associate Director, Mass Spectrometry & Biomarkers (Hybrid)

Takeda; Warszawa; Hybrid; PLN 328,000 - 451,000; Full time

Benefits offered by this job

Hybrid work policy

Global Top Employer recognition

Job summary

Takeda is seeking an Associate Director, Mass Spectrometry, Translational Biomarkers and Bioanalytics, to lead bioanalytical strategy for global clinical development programs. The role shapes scientific direction, oversees method development and validation, and ensures timely, compliant delivery of PK, immunogenicity, and biomarker data.

The Poland-based position includes EU and global regulatory responsibilities, vendor oversight, and collaboration across Translational Biomarkers and

Qualifications

• Doctoral or equivalent with substantial industry experience in bioanalytics.
• Deep expertise in bioanalytical chemistry, immunology, and drug development.
• Proven track record in biomarker technologies and regulated bioanalysis.

Responsibilities

• Lead bioanalytical strategy and biomarker strategy across global programs.
• Provide SME oversight of method development, validation, and lifecycle management.
• Ensure regulatory compliance and inspection readiness across EU and global settings.
• Collaborate with Quality for vendor qualification, audits, and data integrity.
• Review PK, immunogenicity, and biomarker results and contribute to study reports.
• Support regulatory submissions and health authority responses with robust documentation.
• Lead and coordinate cross-functional teams to meet study timelines.

Skills

Bioanalytical chemistry

Immunology

Biomarker technologies

Mass spectrometry

Regulatory compliance

Vendor oversight

Cross-functional leadership

Communication

English fluency

Education

PhD in a relevant scientific discipline

Master of Science with substantial industry experience

Bachelor's degree with extensive experience

Tools

LC-MS/MS

Bioanalytical method development

Data analysis and reporting

Job description

Takeda is seeking an Associate Director, Mass Spectrometry, Translational Biomarkers and Bioanalytics, to lead bioanalytical strategy for global clinical development programs. The role shapes scientific direction, oversees method development and validation, and ensures timely, compliant delivery of PK, immunogenicity, and biomarker data.

The Poland-based position includes EU and global regulatory responsibilities, vendor oversight, and collaboration across Translational Biomarkers and