Sr. Scientist – Reference Standards Qualification
Core
Managing the lifecycle of reference standards, assay controls, and critical reagents for late-stage or commercial biological products.
Role type
Senior Scientist (Analytical Lifecycle Management)
Builds
Reference standards, assay controls, and critical reagents for biologics and cell/gene therapy programs
Domain
Biopharmaceuticals / Cell and Gene Therapy / Analytical Chemistry
Required skills
Reference standard qualification and bridging, stability monitoring, GMP compliance, analytical method performance monitoring, technical writing for regulatory documents, data trending and statistical analysis (JMP), protein/oligonucleotide/molecular biology/immunoassay techniques
Preferred skills
Experience with cell and gene therapy, biologics, or CRISPR gene editing programs
Technologies
JMP
Responsibilities
Support lifecycle management of reference standards, assay controls, and critical reagents including qualification, bridging, characterization, and stability monitoring; Author and review protocols, technical reports, Certificates of Analysis (CoAs), and comparability assessments; Monitor analytical method performance through data trending and periodic assessment of critical reagent suitability; Collaborate with internal stakeholders and external testing partners on lifecycle management activities
Seniority
Senior, hands-on IC
