Principal Bioanalytical Scientist, Biomarker Lead

Mygwork; Massachusetts; On-site; USD 141,000 - 188,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Performance bonus

Equity plan

Job summary

Biogen in the United States is seeking a Principal Scientist to lead bioanalytical strategy, assay development, validation, and CRO oversight to underpin discovery through regulatory submissions. The role partners across teams to ensure high-quality data that informs critical development decisions and regulatory filings.

You will oversee biomarker and PD/PK assays, drive method development on multiple platforms, and guide data interpretation while maintaining regulatory readiness and scientific

Qualifications

• PhD with 5+ years of industry experience in bioanalysis or biomarker sciences.
• MS with 8+ years of industry experience in bioanalytical settings.
• Experience developing and implementing biomarker and bioanalytical assays.

Responsibilities

• Serve as the bioanalytical lead on programs, guiding assay strategies and data interpretation.
• Develop and validate bioanalytical assays (PK, ADA) and support biomarker methods.
• Lead design and execution of assay development and regulatory-facing data packages.
• Provide scientific oversight of CROs and external labs, including vendor management.
• Review validation reports and data to ensure regulatory compliance and quality.
• Investigate assay issues and recommend corrective actions.
• Develop, transfer, and validate bioanalytical and biomarker assays across platforms.
• Evaluate novel biomarker technologies and their fit for use.
• Monitor assay performance, QC trends, and cross-study comparability.
• Interpret data and communicate risks and recommendations to teams.
• Contribute to IND, CTA, BLA submissions and regulatory documentation.
• Support audits/inspections through bioanalytical documentation and study records.

Skills

Bioanalytical leadership

Assay development

Regulatory submissions

CRO oversight

Data interpretation

Scientific writing

Project collaboration

Education

PhD in Immunology/related field

MS in related field

Job description

Biogen in the United States is seeking a Principal Scientist to lead bioanalytical strategy, assay development, validation, and CRO oversight to underpin discovery through regulatory submissions. The role partners across teams to ensure high-quality data that informs critical development decisions and regulatory filings.

You will oversee biomarker and PD/PK assays, drive method development on multiple platforms, and guide data interpretation while maintaining regulatory readiness and scientific