Principal Bioanalytical Assay Manager

Job description

We advance science so that we all have more time with the people we love. The Principal BioAnalytical Assay Manager (Pr. BioA Mgr) is accountable for assay technical outsourcing oversight and lifecycle management of BAS assays that support non-clinical and clinical study bioanalysis for PK/TK, ADA, NAb, and biomarkers on various technologies and platforms (LC MS/MS, LBA, Cell-based). The Pr.BioA Mgr applies comprehensive technical bioanalysis expertise and global regulatory knowledge to the collaborative (internal/external) lifecycle management of BAS assays at the CROs, maintaining a high level of bioanalytical sustainability and quality study data. Opportunity: As an integral member of our dynamic team, you will be: Developing and maintaining strategic collaborations with key stakeholders to understand current and future portfolio needs for BAS deliverables. Through collaborative planning and leadership, ensure uninterrupted non-clinical and clinical sample analysis at global strategic/preferred CRO partners through a comprehensive technical support of assay transfer, feasibility, validation/qualification and lifecycle management. Identifying, collaborating, and executing optimiz...