Manager -1 Biotechnology
Core
Lead bioanalytical assay development, validation, and regulatory dossier preparation for therapeutic peptides and proteins in a regulated environment.
Role type
Manager, Bioanalytical Regulatory Affairs
Builds
Bioanalytical assays and regulatory documentation for pre-clinical and clinical studies
Domain
Biotechnology / Regulatory Affairs
Required skills
Bioanalytical assay development, PK/PK/ADA/NAB assay validation, CRO management, regulatory query resolution, technical dossier drafting, experimental design review, method validation oversight
Preferred skills
Innate and adaptive immune response assessment, reagent generation oversight
Technologies
GLP, GCLP, CRO platforms
Responsibilities
Partner with CROs for bio analytical assay development; Lead TK, PK, ADA & NAB assay development and validation; Lead evaluation of innate and adaptive immune responses; Provide scientific and operational oversight of bioanalytical activities; Identify and screen CROs for bioanalytical services; Review method development and validation reports; Draft technical content for regulatory dossiers; Manage regulatory queries.
