Clinical Immunogenicity Lead - Hybrid Bio/Pharma Innovator

Millipore Corporation; Billerica (MA); Hybrid; USD 127,000 - 215,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Benefits package

Job summary

EMD Serono in the United States seeks a Clinical Immunogenicity Lead to drive immunogenicity strategies and oversee bioanalytical work in R&D. You will collaborate with translational science, clinical pharmacology, biostatistics, pharmacovigilance, and regulatory teams to advance novel biotherapeutics and support regulatory submissions.

You will coordinate external partners for immunogenicity assay work, validate bioanalytical assays, review data, and present complex results to senior

Qualifications

• Ph.D. in Biochemistry, Biology, Chemistry, or related field.
• 5+ years in pharma/CRO in immunogenicity or bioanalytical roles.
• Experience with NBEs, ADCs, and other novel modalities.
• Experience supporting regulatory submissions (INDs/BLAs/CSRs).

Responsibilities

• Lead immunogenicity strategies across bioanalytical activities.
• Oversee external partners/CROs for immunogenicity assay work.
• Coordinate validation of bioanalytical assays for immunogenicity and PK.
• Prepare regulatory documentation sections (IND/BLAs, CSRs).
• Present complex data to cross-functional teams and leadership.

Skills

Immunogenicity strategy leadership

ADA data analysis

Regulatory submissions

External partnerships management

Bioanalytical coordination

Cross-functional collaboration

Data interpretation

Education

Ph.D. in Biochemistry/Biology/Chemistry or related field

Job description

EMD Serono in the United States seeks a Clinical Immunogenicity Lead to drive immunogenicity strategies and oversee bioanalytical work in R&D. You will collaborate with translational science, clinical pharmacology, biostatistics, pharmacovigilance, and regulatory teams to advance novel biotherapeutics and support regulatory submissions.

You will coordinate external partners for immunogenicity assay work, validate bioanalytical assays, review data, and present complex results to senior