Sr. Scientist I Immunoassay
Core
Develop and validate quantitative immunoassay methods for pharmacokinetic and anti-drug antibody studies in compliance with regulatory standards.
Role type
Senior Scientist I, Immunoassay
Builds
Validated immunoassay methods and study data
Domain
Pharmaceutical research / Analytical chemistry
Required skills
ELISA, MSD platform, method development, method validation, GLP/GCP/GMP compliance, data analysis, reagent preparation, instrument operation, deviation reporting
Preferred skills
ICH M10 guidance, CRO experience, pharmaceutical industry knowledge
Technologies
ELISA, MSD platform
Responsibilities
Execute routine sample analysis studies with increased throughput, independently operate and maintain analytical instruments, independently execute method validation and qualification projects, independently design and execute complex method development projects, review laboratory documents and notebooks for compliance, act as a liaison with Sponsors, assist in training new staff members.
Seniority
Senior, hands-on IC