Large Molecule Bioanalysis Scientist
Core
Develop and validate ligand binding assay (LBA) methods for large molecule biologics to support human pharmacokinetics, PD biomarkers, and immunogenicity studies.
Role type
Senior IC analytical chemistry scientist (large molecule bioanalysis)
Builds
Validated bioassay methods and study reports for clinical development
Domain
Biopharmaceuticals / Large molecule biologics
Required skills
Ligand binding assay (LBA) method development and validation, Monoclonal antibody (mAb) and antibody drug conjugate (ADC) PK analysis, Anti-drug-antibody (ADA) and neutralizing antibody (NAb) analysis, ELISA, ECL, Flow Cytometry, real time-PCR, Study protocol drafting, Good Laboratory Practices (GLP) compliance
Preferred skills
Supervision of technicians, Project management, Direct working experience in GLP
Technologies
ELISA, ECL, Flow Cytometry, real time-PCR
Responsibilities
Develop and validate LBA methods for large molecule biologics; Draft study protocols/plans, acquisition methods, and study reports; Supervise all phases of bioassays to support human pharmacokinetics, PD Biomarkers and Immunogenicity studies; Supervise technicians for performing method development, validation, and sample analysis; Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence etc.
Seniority
Senior, hands-on IC
