Senior Scientist, Late Development Vaccines, Serology

Job Description

The PDMB Regulated Bioanalytics Department is seeking a Senior Scientist for the Serology Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA.  At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.  A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.  As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our Company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA. 

The primary role of the successful candidate will be to optimize, validate, and implement immunology-based bioanalytical assays in support of late-stage vaccine programs.  The individual will be responsible to contribute with limited supervision to all aspects of assay development on robotic platforms, technology transfer, validation, troubleshooting, and phase III sample testing support.  The ideal candidate will have solid laboratory experience in the field of immunology and/or cell biology, deploying immunological/serological based bioanalytical assays in a GxP setting to drive clinical studies forward. The candidate should be current on state-of-the art technologies and is expected to champion ongoing improvements in automated assay conduct.  Providing expert technical representation on multidisciplinary teams will be expected. 

Education Minimum Requirement

B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with at least 7 years, M.S. with at least 4 years, or Ph.D. with hands-on experience in related field 

Responsibilities

• Provide scientific input to the design and execution of ligand binding assays (LBA), such as ELISA, Luminex, and/or cell-based assays  

• Develop expertise with laboratory automation (e.g., robotic platforms, liquid handlers) to drive end-to-end fully automated assay to support late stage clinical testing 

• Responsible for the execution of method optimization, troubleshooting, and clinical sample analysis within a GxP laboratory 

• Act as subject matter expert with internal or external teams and during audit on serology methods and platforms (e.g., Luminex) and associated lab automation 

• Accountability for generated data.  May review data generated by others 

• Understand and apply regulatory/compliance/scientific requirements relative to their role 

• May publish and/or present technical papers to external audiences; participate in  internal publications 

• Use own scientific judgment to apply and adapt standard methods and techniques by applying prior work experience, consulting others appropriately 

Required Experience & Skills

• Critical thinking and good trouble-shooting skills  

• Experience with immunoassays such as ELISA, AlphaLisa, multiplexed LBA and/or Luminex platforms  

• Experience optimizing, validating, and using immunoassays in support of non-clinical and/or clinical studies 

• Adherence to basic safety procedures in a BSL2 laboratory  

• Experience operating in a GxP laboratory  

• Good verbal and written communication  

• Ability to follow procedures and thoroughly document experiments  

• Ability to communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams  

Preferred Experience & Skills

• Experience with cell-based assays in the context of immune response characterization, such as viral neutralization, PRNT/VRNT/FRNT, ELISpot, or multi-color flow cytometry  

• Familiarity with liquid handlers and other automation platforms for sample preparation and assay process   

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously 

• Experience with Laboratory Information Management Systems (LIMS), electronic laboratory notebooks, and other scientific applications 

• Experience performing computer system validations 

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