Bioanalytical Manager
3 weeks ago
Meet is partnering with a growing biotech in South San Francisco to fill a Bioanalytical Manager / Senior Manager opportunity.
About the Role:We are seeking a highly experienced Bioanalytical Manager to oversee internal and external assay development across multiple programs through all stages of drug development. The ideal candidate will have a strong background in assay development and validation, with a current understanding of industry guidance for regulated bioanalysis.
Key Responsibilities:- Develop and implement bioanalytical strategies to support preclinical and clinical studies
- Manage external vendors/CROs to develop, validate, and maintain bioanalytical methods
- Oversee transfer, validation, and lifecycle management of assays
- Provide technical support and expertise for troubleshooting
- Responsible for internal assay development and optimization
- Bioanalytical data review, analysis, interpretation, delivery, and report writing in support of regulatory filings within program timelines
- Oversight of biosample collection and related documents
- Work closely with cross-functional teams: Research and Development for development of stage-appropriate assays; Clinical Operations for biosample logistics; Clinical Development for clinical data management and presentation
- Familiar with a wide range of bioanalytical platforms (MSD and plate-based analysis, cell-based assays)
- Cell-based functional assay experience across different programs is strongly preferred
- Strong technical background in assay development with a keen eye to detail and an ability to creatively tackle technically challenging assays
- Technical document writing and review in creation of reports, both in the lab and with external lab vendors, SOPs, and regulated documents
- Strong background in project management, including balancing competing timelines across multiple vendors and programs
- Experience in early-phase clinical studies and requirements for labs for study start-up and adapting clinical protocols to bioanalytical lab support
- CRO and/or specialty lab vendor management experience
- Knowledge and understanding of interfacing between Central Labs, Specialty Labs, and Bioanalytical Labs
- Ability to work in a fast-paced environment requiring flexibility and clear communication skills
- B.S. with 7+ years of relevant experience or M.S. with 5+ years of relevant experience required
- Experience in project leadership and a track-record of successful development and transfer of assays to GLP laboratories for validation is required
- Experience developing, transferring, and managing bioanalytical assays for large molecules is required
- Central lab oversight experience is preferred
- A mix of direct CRO and sponsor working experience is preferred
- Experience working independently with external vendors/CROs, with strong interpersonal capabilities
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