Play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and...
You will oversee the planning, organizing, directing, and evaluating of routine external QC activities, including stability and project deliverables of external QC laboratories....
Develop and validate ligand-binding assays to support bioanalysis (pharmacokinetics, biomarkers, immunogenicity assessment) for preclinical and clinical studies; Oversee and...
Key technical leader in USP process technologies, accountable for coordination of technical and laboratory activities in support of technology transfer, continued cGMP...
Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, ensuring study deliverables are met on time, on budget, and with the appropriate...