Senior Scientist, Regulated Bioanalytics Late-Stage Vaccine Clinical Development, Serology

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Scientist for the Serology / Molecular> 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 design and develop immunology-based bioanalytical assays in support of early vaccine programs.  The individual will be responsible to contribute with limited supervision to all aspects of assay development, technology transfer, and/or troubleshooting.  The ideal candidate will have solid laboratory experience in the field of immunology and/or cell biology, a broad skill set, encompassing working with primary immune cells to developing bioanalytical assays capable to meet clinical assay requirement. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes.  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 and/or cell-based assays, such as luciferase reporter assays 

• Responsible for the execution of method development, troubleshooting, and/or pre-clinical/clinical sample analysis as needed 

• Contribute to the assessment and implementation of new analytical technologies 

• Serve as an internal subject matter expert on developed assays 

• Accountability for generated data

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

• May publish and/or present technical papers to external audiences; participates in significant 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 in general cell biology methods, including maintenance of cell lines and/or primary cells 

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

• Adherence to basic safety procedures in a BSL2 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 

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