Senior Bioanalytical Scientist - PK & Immunogenicity

Hemab Therapeutics; København; Presencial; DKK 800.000 - 1.000.000; Jornada completa

Descripción de la vacante

Hemab Therapeutics is seeking a Senior/Principal Scientist to lead bioanalytical work for development programs, from nonclinical to clinical stages. You will own strategy and collaborate with external labs to ensure PK, ADA/NAb and biomarker data meet regulatory timelines.

You’ll manage CROs, oversee assay development and validation, and help shape the portfolio's bioanalytical platform as Hemab grows, enabling robust decision-making for regulatory submissions.

Formación

• Demonstrated bioanalytical experience supporting biologics through nonclinical and clinical development.
• Experience overseeing outsourced assay development, validation and clinical sample analysis.
• Strong knowledge of ligand-binding assays and LC-MS/MS, including troubleshooting with external labs.
• Working knowledge of ICH M10, immunogenicity guidance and GLP/GCP requirements.
• Experience working with clinical sample logistics, bioanalytical data and cross-functional study teams.
• Ability to take ownership of scientific decisions, manage competing priorities and communicate clearly.

Responsabilidades

• Own the bioanalytical strategy and delivery for assigned development programs.
• Lead outsourced PK, ADA/NAb and PD/biomarker assay development, transfer, validation and sample analysis.
• Manage CRO relationships, including scientific oversight, timelines, budgets and resolving issues before they affect studies.
• Review bioanalytical plans, validation reports and study data against ICH M10, FDA/EMA guidance and GLP/GCP expectations.
• Work with Clinical Operations, central laboratories and study sites to get clinical samples collected, shipped and reconciled correctly.
• Investigate assay failures, unexpected results and deviations, and agree practical solutions with external laboratories.
• Contribute bioanalytical content to regulatory submissions and responses to health authority questions.
• Help develop consistent, useful ways of working as Hemab's portfolio grows.

Conocimientos

bioanalytical experience

outsourced assay oversight

LC-MS/MS knowledge

clinical sample logistics

Descripción del empleo

Hemab Therapeutics is seeking a Senior/Principal Scientist to lead bioanalytical work for development programs, from nonclinical to clinical stages. You will own strategy and collaborate with external labs to ensure PK, ADA/NAb and biomarker data meet regulatory timelines.

You’ll manage CROs, oversee assay development and validation, and help shape the portfolio's bioanalytical platform as Hemab grows, enabling robust decision-making for regulatory submissions.