Sr. Scientist, Pharmacokinetics

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics Regulated Bioanalytics Department is seeking a Senior Scientist for the 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 immunoassays), and cell-based assays (e.g., neutralization 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 molecular-based bioanalytical assays in support of late stage vaccine programs.  This colleague will be accountable 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 molecular biology, deploying primarily PCR 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 molecular biology based methods including PCR, qPCR, DNA extraction, and related techniques 
• 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 molecular methods and platforms (e.g., Quant Studios, KingFishers) 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 molecular assays such as PCR, qPCR, multiplexed PCR assays, and DNA extractions 
• Experience optimizing, validating, and using molecular-based assays 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 the development and implementation of next-generation sequencing (NGS) and/or other DNA sequencing assays
• 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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