Principal Bioanalytical Assay Manager

Genentech•Daly City, CA

About The Position

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 optimized business and technical procedures and tools to streamline related BAS assay technical outsourcing and lifecycle management processes (within BAS and at CROs) Overseeing GNE assay lifecycle management at CROs, internal validation/qualification document management, bioanalysis troubleshooting and unexpected results investigations. Support global regulatory submissions and internal/external inspections. Serving as the front line technical contact for one or more CROs. Guide and influence the technical on-boarding, assay transfer, validation, and lifecycle management to CRO principal investigators and BAS key stakeholders. Subject matter expert on global bioanalytical method validation/qualification regulatory requirements (FDA/EMA/NMPA/ICH M10) of PK, ADA, NAb, and biomarker assays. Guide and influence the internal/external interpretation of these regulatory requirements, contributing to IND/BLA/NDA/CTA/sBLA submissions. Reviewing and assessing assay performance data for trends that may require assay lifecycle management in order to maintain a high level of bioanalytical sustainability and quality study data. Report out relevant assay performance data and key messages to appropriate internal/external key stakeholders and collaborators. Proactively monitor industry trends and emerging technologies to implement innovative bioanalytical strategies that enhance workflow efficiencies.

Requirements

Bachelors or higher degree in scientific discipline and experience
7-10 years of drug development experience in pharmaceutical or biotechnology industry that includes bioanalytical work (e.g., assay development, assay validation/qualification, biosample analysis), experience in outsourcing and CRO oversight
Comprehensive understanding of drug development and application of technologies for bioanalysis with experience on the application of LC/MS for large molecules along with ligand binding
General understanding of global health authority regulatory method validation guidance (FDA/EMA/NMPA/ICH M10) for non-clinical and clinical assays and study sample analysis

Nice To Haves

Experience working in relationship-oriented strategic collaborations in a global internal/external team matrix environment is preferred.

Responsibilities

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 optimized business and technical procedures and tools to streamline related BAS assay technical outsourcing and lifecycle management processes (within BAS and at CROs)
Overseeing GNE assay lifecycle management at CROs, internal validation/qualification document management, bioanalysis troubleshooting and unexpected results investigations.
Support global regulatory submissions and internal/external inspections.
Serving as the front line technical contact for one or more CROs.
Guide and influence the technical on-boarding, assay transfer, validation, and lifecycle management to CRO principal investigators and BAS key stakeholders.
Subject matter expert on global bioanalytical method validation/qualification regulatory requirements (FDA/EMA/NMPA/ICH M10) of PK, ADA, NAb, and biomarker assays.
Guide and influence the internal/external interpretation of these regulatory requirements, contributing to IND/BLA/NDA/CTA/sBLA submissions.
Reviewing and assessing assay performance data for trends that may require assay lifecycle management in order to maintain a high level of bioanalytical sustainability and quality study data.
Report out relevant assay performance data and key messages to appropriate internal/external key stakeholders and collaborators.
Proactively monitor industry trends and emerging technologies to implement innovative bioanalytical strategies that enhance workflow efficiencies.