Principal Scientist, Biomarker Bioanalytical Sciences
Biogen
August 20, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as bioanalytical lead for assigned discovery/development programs; develop biomarker and bioanalytical strategies.
- Develop/execute fit-for-purpose bioanalytical approaches (PK, ADA) and implement biomarker methods (TE, PD, Disease).
- Lead assay development, analytical validation, and sample analysis plans for program and regulatory needs.
- Provide scientific oversight of CROs/external labs: development, validation, analysis, troubleshooting, data review, and vendor management.
- Review protocols, validation/sample reports, and bioanalytical data packages for quality, regulatory compliance, and fitness-for-purpose.
- Investigate assay issues/deviations and perform root-cause analyses with corrective-action recommendations.
- Optimize/transfer/validate assays on existing and emerging platforms; evaluate novel biomarker technologies.
- Monitor assay performance/QC trends/robustness and ensure cross-study comparability.
- Interpret data and communicate findings, risks, and recommendations to stakeholders.
- Contribute to IND/CTA/BLA and other regulatory submission content; support audits/inspections; support publications and presentations.
Qualifications (Required):
- PhD or MS in Immunology, Cellular and Molecular Biology, or related field.
- PhD (5+ years) or MS (8+ years) relevant industry experience.
- Experience developing/implementing biomarker and bioanalytical assays across discovery and clinical.
- Method development/validation expertise in regulated environments; sample analysis/data review experience.
- Familiarity with regulatory biomarker/bioanalytical requirements; CRO oversight.
- Strong technical writing, analytical interpretation, and communication; independent, matrixed teamwork; ligand-binding and cell-based assay technology.
Preferred:
- Clinical biomarker program experience; publication record.
- Authored/defended regulatory bioanalytical content (IND/CTA/BLA/MAA).
Benefits (as listed):
- Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability; paid vacation; holidays/sick time; paid maternity/parental leave; 401(k) with match; stock purchase plan; tuition reimbursement; Employee Resource Groups.
- Serve as bioanalytical lead for assigned discovery/development programs; develop biomarker and bioanalytical strategies.
- Develop/execute fit-for-purpose bioanalytical approaches (PK, ADA) and implement biomarker methods (TE, PD, Disease).
- Lead assay development, analytical validation, and sample analysis plans for program and regulatory needs.
- Provide scientific oversight of CROs/external labs: development, validation, analysis, troubleshooting, data review, and vendor management.
- Review protocols, validation/sample reports, and bioanalytical data packages for quality, regulatory compliance, and fitness-for-purpose.
- Investigate assay issues/deviations and perform root-cause analyses with corrective-action recommendations.
- Optimize/transfer/validate assays on existing and emerging platforms; evaluate novel biomarker technologies.
- Monitor assay performance/QC trends/robustness and ensure cross-study comparability.
- Interpret data and communicate findings, risks, and recommendations to stakeholders.
- Contribute to IND/CTA/BLA and other regulatory submission content; support audits/inspections; support publications and presentations.
Qualifications (Required):
- PhD or MS in Immunology, Cellular and Molecular Biology, or related field.
- PhD (5+ years) or MS (8+ years) relevant industry experience.
- Experience developing/implementing biomarker and bioanalytical assays across discovery and clinical.
- Method development/validation expertise in regulated environments; sample analysis/data review experience.
- Familiarity with regulatory biomarker/bioanalytical requirements; CRO oversight.
- Strong technical writing, analytical interpretation, and communication; independent, matrixed teamwork; ligand-binding and cell-based assay technology.
Preferred:
- Clinical biomarker program experience; publication record.
- Authored/defended regulatory bioanalytical content (IND/CTA/BLA/MAA).
Benefits (as listed):
- Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability; paid vacation; holidays/sick time; paid maternity/parental leave; 401(k) with match; stock purchase plan; tuition reimbursement; Employee Resource Groups.