Principal Scientist, Immunogenicity & nAb Assay Development

Boehringer Ingelheim GmbH; Ridgefield, Northern (CT, KY); Hybrid; USD 141,000 - 211,000; Full time

Job summary

Boehringer Ingelheim is seeking a Principal Scientist to join the DMPK group at our Ridgefield, CT headquarters. The role centers on developing cell-based and competitive ligand binding assays to evaluate neutralization activity of anti-drug antibodies in clinical samples for immunogenicity assessments.

You will lead assay development efforts, oversee CRO collaborations, and mentor junior scientists while ensuring compliance with GLP/GCP and regulatory expectations.

Qualifications

• Ph.D. with 5+ years in related field.
• 3+ years hands-on nAb assay development experience.
• Experience in regulated bioanalytical environment (GLP/GCP).
• Experience overseeing CRO activities.
• Experience with cell-based and ligand-binding immunoassays.
• Knowledge of global regulatory guidance and industry best practices.

Responsibilities

• Independently designs and performs scientific experiments with predefined goals and developed methodologies.
• Serve as scientific monitor for assay performance and project management at external CROs.
• Contributes to defining R&D team goals and collaborates with scientists across functions.
• Prepares clear technical reports, publications and oral presentations for senior management.
• Demonstrates expertise and guides projects, evaluating new technologies and concepts for multiple projects.
• Develops broad knowledge by interpreting current literature relevant to R&D projects.
• Assumes responsibility for direct reports as needed including mentoring staff.
• Maintains compliance with regulations and SOPs; ensures proper records and safety.
• Contributes to departmental administration and budget considerations.

Skills

nAb assay development

GLP/GCP knowledge

Regulatory knowledge

Cross-functional collaboration

Scientific writing

Education

Ph.D. degree in related field

Tools

EnVision

SpectraMax

MSD

Flow cytometry

Job description

Boehringer Ingelheim is seeking a Principal Scientist to join the DMPK group at our Ridgefield, CT headquarters. The role centers on developing cell-based and competitive ligand binding assays to evaluate neutralization activity of anti-drug antibodies in clinical samples for immunogenicity assessments.

You will lead assay development efforts, oversee CRO collaborations, and mentor junior scientists while ensuring compliance with GLP/GCP and regulatory expectations.