Sr. Scientist, Pharmacokinetics

Job Description

Description

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) at Spring House Innovation Park is seeking a Senior Scientist for the Early Development Vaccine team located at our Company's new state-of-the-art Spring House Innovation Park research facility in Lower Gwynedd, PA.  At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable early phase 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. 

The primary role of the successful candidate will be to optimize, validate, and implement molecular, serology or cell-based bioanalytical assays in support of early (Phase I and II) vaccine clinical programs.  The individual will be responsible to contribute with limited supervision to all aspects of assay development, transfer to robotic platforms, technology transfer, assay qualification/validation, troubleshooting, and phase I/II sample testing support.  The ideal candidate will have solid laboratory experience in the field of bioanalytical assay development, qualification/validation.  Experience in developing and deploying assays in a GxP environment is desired. 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 (e.g. NGS, PCR, qPCR, DNA extraction) or immunogenicity (e.g. ELISA) or cell-biological methods (e.g. VRNT) techniques.

• Develop expertise with laboratory automation (e.g., robotic platforms, liquid handlers) to drive end-to-end fully automated assay to support early (Phase I and II) 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 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 

• 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 immunoassay platforms such as our Company, Luminex, ELISA, AphaLISA or Experience with molecular assays such as Next Generation Sequencing,  PCR, qPCR, multiplexed PCR assays, and DNA extractions

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

• Strong attention to detail with the ab