Principal Scientist - Bioanalytical Development & Vaccines Clinical Assays Job

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

- Lead development or transfer of immunochemistry-based bioanalytical methods in Pharmacokinetic (PK), Toxicokinetic (TK), Immunogenicity and biomarker areas to support Merck biologics and vaccine programs. Responsible for troubleshooting of issues occurred during method development or in-study phase. - Develop and implement new technologies including but not limited to immunoassays and LCMS assays for use in PK, TK and immunogenicity studies for novel biologics and vaccines. - Serve as Principle Investigator for method validation to support pre-clinical/clinical sample analysis studies. - Ensure GLP compliance. - Prepare/review study protocols and assay validation reports. - Address QA findings and observations. - Interact with sample manager, bioanalyst, instrument scheduler, report writer, QC/QA, etc to track project progress and ensure on time delivery.

Qualifications Education: - PhD Degree in molecular biology, immunology, microbiology, pharmacology, biochemistry, cell biology or related discipline. Required: - A minimum of 8 years of experience in development, optimization, validation and execution of immunoassays for PK and immunogenicity assessment in pharmaceutical/biotechnology or CRO industry. - Familiar with regulatory guidelines related to PK, immunogenicity assessment and vaccine clinical testing. - Excellent written and verbal communication skills. - Ability to openly share information and work in a team setting. Preferred: - Bioanalytical assay development including PK and immunogenicity - Vaccine clinical testing - Experience with MSD, Luminex, Singulex, GyroLabs or MRM-mass spectrometry are strongly preferred. - Experience in cell culture, flow cytometry and cell-based assays is a plus.