Senior Bioanalytical Scientist: PK & Immunogenicity

Biogen; Cambridge (MA); On-site; USD 122,000 - 163,000; Full time

Job summary

Biogen, based in Cambridge, MA, seeks a Senior Scientist to lead PK, biomarker, and immunogenicity assays across clinical programs. You will oversee CROs, develop strategies aligned with FDA/EMA/ICH, and contribute to regulatory submissions.

Strong emphasis on data interpretation and cross-functional collaboration with Clinical Development and Regulatory Affairs. The role requires hands-on assay development across platforms such as ELISA and MSD, with a focus on assay validation and regulatory

Qualifications

• PhD with 4+ years of industry experience in bioanalysis.
• Hands-on PK, biomarker, ADA/NAb assay development experience.
• Experience overseeing CROs and regulatory submissions.

Responsibilities

• Lead development, optimization, and validation of PK, biomarker, ADA, NAb assays.
• Develop immunogenicity strategy aligned with modality and clinical stage.
• Oversee CROs with scientific direction and data review.
• Collaborate with Clinical Development, Translational Medicine, Safety, and Regulatory.
• Prepare regulatory responses and support health authority interactions.
• Lead study/ program teams and contribute to manuscripts and presentations.

Skills

PK/Immunogenicity bioanalysis

Bioanalytical assay development

Regulatory submissions

CRO management

Data interpretation

Scientific writing

Cross-functional collaboration

Education

PhD in Immunology / related field

MS in related field

BS in related field

Tools

ELISA

MSD

Simoa

Cell-based assays

PK/PD platforms

Job description

Biogen, based in Cambridge, MA, seeks a Senior Scientist to lead PK, biomarker, and immunogenicity assays across clinical programs. You will oversee CROs, develop strategies aligned with FDA/EMA/ICH, and contribute to regulatory submissions.

Strong emphasis on data interpretation and cross-functional collaboration with Clinical Development and Regulatory Affairs. The role requires hands-on assay development across platforms such as ELISA and MSD, with a focus on assay validation and regulatory