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BioAnalytical Manager III
Ref No.: 20-01169
Location: South San Francisco, California
BioAnalytical Manager III
Biopharmaceutical Industry
South San Francisco, CA 94080

Contract-to-Hire: 3/16/2020 - 3/16/2021

Join a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.  The world's leading biotech company with multiple products on the market and a promising development pipeline. Join a team of highly dedicated, passionate individuals who take pride in a culture of openness, integrity and creativity. 


We are searching for a BioAnalytical Manager II experienced in BioAnalytical Sciences who will develop implement and provide strategic direction for state of the art bioanalytical methods and automation systems.
Client data and expertise enable the characterization of the pharmacokinetic, immunogenic and in vitro biological activities of *** biotherapeutics during drug development and throughout the product life cycle. The BioAnalytical Manager (BAM) is a project management role in Client.
Duties:
  • BAM works with clinical study teams, contracting group, data group, DMPK, Client, central labs and contract labs to outsource and manage biosample (PK/ATA) analysis.
  • The BAM is simultaneously assigned to multiple studies and is an agenda-driven ad-hoc member of the clinical study management team (SMT) for each study.
  • The BAM will drive the development of assay vendor SOWs, managing vendor contracts, including review of invoices, ensuring receipt of SOW deliverables, resolving or escalating issues where needed, and closing contracts
  • Assist with identifying and on-boarding assay vendors including SOW development, budget planning, and specifying data formats Preparing vendor oversight plans for each study as needed.
  • Ensuring alignment with cross-functional stakeholders and document team decisions in the PK/ATA Sample Flow Diagram Developing timelines for PK and ATA data for managing contract labs to ensure samples are tested according to protocol/team timelines, data is returned in the specified format, and all SOW specified deliverables are met
  • Oversee shipping and receipt of biosamples from central labs to assay laboratories
  • Providing biosample metrics and status updates to teams as requested Supporting clinical study teams (PET/SMT), pharmacology teams through attending appropriate meetings as needed
  • Serving as the on-going operational point of contact between internal gRED functions and assay vendors for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reportable tracking Making arrangement for samples and data handling/archiving at the completion of the study
Required Skills:
  • Bachelor’s degree or Master’s degree in a scientific discipline 5 + years of experience in related field that includes experience working in the biotech industry and in clinical study teams with involvement in the processing and/or analysis of biological samples
  • Ability to deliver results successfully, collaborating with multi-cultural and geographically diverse teams
  • Technical experience/knowledge of bioanalytical assay methods. Ability to work in a highly matrixed organization in a positive and collaborative manner 

Education:
Bachelor’s degree or Master’s degree in a scientific discipline