Location: 
South San Francisco
Employment Type: 
Contract
Job ID: 
134192
Description: 

Duties:

BioAnalytical Sciences (BAS) develops implements and provides strategic direction for state of the art bioanalytical methods and automation systems.  BAS 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 BAS.  BAM works with clinical study teams, contracting group, data group, DMPK, BAS, 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 responsibilities for BioAnalytical Manager include: 

Driving 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 
Overseeing 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 

 
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 

Strong organizational skills with attention to details 
Independently  manage multiple competing priorities, while working on multiple projects simultaneously 
Excellent communication and presentation skills and effective influencing/negotiating skills. 

 

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