The Senior Scientist leads the design, development, and lifecycle management of complex bioassays for biologics and advanced therapies
Job Summary
The Senior Scientist leads the design, development, and lifecycle management of complex bioassays for biologics and advanced therapies.
This role ensures methods are fit-for-purpose and phase-appropriate while providing scientific oversight for troubleshooting and regulatory compliance.
The position offers the opportunity to drive innovation by evaluating new assay technologies and partnering with automation teams to modernize workflows.
Matching Summary
The Senior Scientist leads the design, development, and lifecycle management of complex bioassays for biologics and advanced therapies.
Skills & Requirements
Must-have
PhD in Biochemistry or related field
Experience with binding and cell-based assays
Knowledge of ICH Q2(R2) and ICH Q14 guidelines
Expertise in potency assay development
Regulatory submission and inspection support
Nice-to-have
Mentoring scientists and cross-functional influence
Automation and digital data capture experience
Continuous improvement in assay throughput
Strategic CMC strategy involvement
Key Requirements
PhD in Biochemistry, Molecular Biology, Biotechnology, Immunology
Industry experience developing binding, enzymatic, and cell-based assays
Demonstrated expertise in potency assay development
Strong working knowledge of ICH Q2(R2), ICH Q14
Proven experience supporting regulatory submissions and inspections