Scientist, Pharmacokinetics

Merck KGaA Darmstadt Germany

302d • Onsite

About The Position

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Department is seeking a Scientist for the Serology Lab team within the Late Development Vaccines bioanalytical group located at our Company's new state-of-the-art Late Development Vaccines 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 new 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 support 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.

Requirements

• Experience with immunoassays such as ELISA, AlphaLisa, multiplexed LBA on our Company and/or Luminex platforms
• Experience optimizing, validating, and using immunoassays in support of non-clinical and/or clinical studies
• Critical thinking and good trouble-shooting skills
• 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
• Capable of working independently, with limited supervision, under project timelines
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously

Nice To Haves

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

Responsibilities

• Support the design, implementation, and validation of ligand binding assays (LBA), such as ELISA, our Company, Luminex, and/or cell-based assays
• Perform laboratory activities for method optimization, troubleshooting, and clinical sample analysis within a GxP laboratory
• 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
• Ensure the timely delivery of high quality clinical bioanalytical data
• Ensure high quality documentation of laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree