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Bioanalytical Manager

2 months ago

South San Francisco, United States Meet Full time

Meet is partnered with a small growing biotech in South San Francisco on a Bioanalytical Manager / Senior Manager opportunity


Our client is looking for a candidate with a strong background in assay development and validation and a current understanding of industry guidance for regulated bioanalysis. Hands-on experience with PK, ADA, neutralizing antibody, and flow cytometry assays, hands-on support working in the lab will be needed in this position. Experience in managing the outsourcing of bioanalytical assays, such as vendor selection and management, technical transfer processes, and lifecycle management of clinical assays is required.



RESPONSIBILITIES:

  • Oversee internal and external assay development across multiple programs through all stages of drug development
  • Review validation protocols, test procedures, raw data, and technical reports to ensure scientific integrity and compliance with GLP, GCLP, and current industry guidance
  • Primary interface and manager of external vendors/CROs supporting preclinical and clinical bioanalytical assay development and management
  • Manage 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 (i.e., lab manuals, sample tracking, etc.)
  • 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
  • Complete lab-based activities as needed
  • Mentor junior research staff
  • Be onsite at the South San Francisco office 4-5 days per week for lab based and meeting based work



QUALIFICATIONS:

  • 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



EDUCATION & PROFESSIONAL EXPERIENCE:

  • 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
  • Candidates with extensive experience developing, managing, and deploying bioanalytical assays at a vendor/CRO may also apply



If you're interested in this opportunity please apply or send your updated resume to carlos@peoplewithchemistry.com